{
 "licence": "CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/), except the WHO ATC codes and DDD values and the NICE, SMC and G-BA content, which are cited under their own terms and are not licensed here",
 "licensor": "Loïc Rigal, Open Health Prices, https://access.loicrigal.com",
 "attribution_required": [
  {
   "source": "fr-bdpm",
   "text": "Source: base de données publique des médicaments, https://base-donnees-publique.medicaments.gouv.fr, mise à jour du 8 octobre 2026."
  },
  {
   "source": "es-nomenclator",
   "text": "Fuente: Ministerio de Sanidad, Nomenclátor de facturación de octubre 2026."
  },
  {
   "source": "es-cima",
   "text": "Fuente: AEMPS, CIMA, consultado el 9 de octubre de 2026."
  },
  {
   "source": "uk-drug-tariff",
   "text": "Drug Tariff Part VIIIA October 2026, NHSBSA Copyright 2026. This information is licenced under the terms of the Open Government Licence."
  },
  {
   "source": "uk-dmd",
   "text": "NHS Dictionary of Medicines and Devices (dm+d), NHSBSA Copyright 2026. This information is licenced under the terms of the Open Government Licence."
  },
  {
   "source": "who-atcddd",
   "text": "ATC codes and DDDs: WHO Collaborating Centre for Drug Statistics Methodology, ATC/DDD Index 2026."
  },
  {
   "source": "ecb",
   "text": "Exchange rates: European Central Bank, euro reference rates of 9 October 2026."
  },
  {
   "source": "ema",
   "text": "Source: European Medicines Agency, medicine data of 9 October 2026, https://www.ema.europa.eu/en/medicines/download-medicine-data"
  },
  {
   "source": "dysnet-teratogens",
   "text": "Teratogen register, DysNet, the dysmelia network, https://www.dysnet.org/knowledge/teratogens/, data built 12 September 2026, CC BY 4.0."
  },
  {
   "source": "nice",
   "text": "Source: National Institute for Health and Care Excellence, technology appraisal guidance, https://www.nice.org.uk"
  },
  {
   "source": "smc",
   "text": "Source: Scottish Medicines Consortium, https://scottishmedicines.org.uk"
  },
  {
   "source": "de-gba",
   "text": "Quelle: Gemeinsamer Bundesausschuss, https://www.g-ba.de"
  },
  {
   "source": "es-aemps-ipt",
   "text": "Fuente: AEMPS, informes de posicionamiento terapéutico, consultado el 9 de octubre de 2026."
  },
  {
   "source": "pubmed",
   "text": "Courtesy of the U.S. National Library of Medicine."
  },
  {
   "source": "who-eml",
   "text": "WHO Model List of Essential Medicines, electronic version (eEML), World Health Organization, CC BY 3.0 IGO."
  },
  {
   "source": "fr-lpp",
   "text": "Source : Assurance Maladie, liste des produits et prestations, version 905 du 8 octobre 2026."
  },
  {
   "source": "us-dmepos",
   "text": "Source: CMS, DMEPOS fee schedule, October 2026."
  },
  {
   "source": "us-hcpcs",
   "text": "Source: CMS, HCPCS Level II file, October 2026."
  },
  {
   "source": "au-prescribed-list",
   "text": "Based on content from the Federal Register of Legislation at 9 October 2026. For the latest information on Australian Government legislation please go to https://www.legislation.gov.au."
  },
  {
   "source": "eu-emdn",
   "text": "EMDN: European Commission, European Medical Device Nomenclature, version 2026."
  }
 ],
 "terms": "https://access.loicrigal.com/en/sources/",
 "generated": "2026-10-09",
 "ema_generated": "09/10/2026 - 18:00",
 "register_built": "2026-09-12",
 "register_url": "https://www.dysnet.org/knowledge/teratogens/",
 "register_data": "https://www.dysnet.org/data/teratogens.json",
 "medicines": {
  "sodium-valproate": {
   "atc": "N03AG01",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-17707",
     "date": "2019-06-12",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3098050",
     "products": [
      "DEPAKINE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par DEPAKINE 400 mg/4 ml, préparation injectable pour voie IV, flacon de 400 mg de poudre, ampoule de 4 ml de solvant est important dans l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette présentation est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la présentation déjà inscrite."
      }
     ]
    },
    {
     "dossier": "CT-14583",
     "date": "2016-06-08",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2640955",
     "products": [
      "DEPAKINE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu de ces spécialités reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-14956",
     "date": "2016-03-16",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2620153",
     "products": [
      "DEPAKOTE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par DEPAKOTE reste important dans l’indication de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-7388",
     "date": "2010-01-13",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "VALPROATE DE SODIUM ARROW L.P."
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par cette spécialité est important."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n'apporte pas d'amélioration du service médical rendu (ASMR V)."
      }
     ]
    },
    {
     "dossier": "CT-4449",
     "date": "2007-05-09",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "VALPROATE DE SODIUM AGUETTANT"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu de cette spécialité est important dans les indications de l’A.M.M."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d’amélioration du service médical rendu."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "DEPAKINE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67623734/extrait",
      "products": 5
     },
     {
      "name": "DEPAKOTE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66508736/extrait",
      "products": 2
     },
     {
      "name": "DIVALCOTE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63413610/extrait",
      "products": 2
     },
     {
      "name": "VALPROATE DE SODIUM AGUETTANT",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67468312/extrait",
      "products": 1
     },
     {
      "name": "VALPROATE DE SODIUM ARROW",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63476258/extrait",
      "products": 1
     },
     {
      "name": "VALPROATE DE SODIUM ARROW L.P.",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69386390/extrait",
      "products": 1
     },
     {
      "name": "VALPROATE DE SODIUM TEVA SANTE L.P.",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62327311/extrait",
      "products": 1
     },
     {
      "name": "VALPROATE DE SODIUM VIATRIS L.P.",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61698947/extrait",
      "products": 1
     }
    ],
    "ES": [
     {
      "name": "DEPAKINE",
      "url": "https://cima.aemps.es/cima/dochtml/ft/48827/FT_48827.html",
      "products": 5,
      "atc": [
       "N03AG01"
      ]
     }
    ],
    "UK": [],
    "IT": [
     {
      "name": "ACIDO VALPROICO E SODIO VALPROATO EG"
     },
     {
      "name": "ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM"
     },
     {
      "name": "ACIDO VALPROICO SANDOZ"
     },
     {
      "name": "DEPAKIN"
     },
     {
      "name": "SODIO VALPROATO AUROBINDO"
     },
     {
      "name": "SODIO VALPROATO AUROBINDO ITALIA"
     },
     {
      "name": "SODIO VALPROATO SEACROSS"
     }
    ],
    "US": [
     {
      "name": "Depakote"
     },
     {
      "name": "Depakote Er"
     }
    ],
    "US_discontinued": [
     {
      "name": "Depacon"
     },
     {
      "name": "Depakene"
     },
     {
      "name": "Depakote Cp"
     },
     {
      "name": "Stavzor"
     }
    ],
    "CA": [
     {
      "name": "APO-DIVALPROEX"
     },
     {
      "name": "APO-VALPROIC ACID"
     },
     {
      "name": "DEPAKENE"
     },
     {
      "name": "EPIVAL"
     },
     {
      "name": "JAMP DIVALPROEX"
     },
     {
      "name": "JAMP VALPROIC ACID ORAL SOLUTION"
     },
     {
      "name": "MYLAN-DIVALPROEX"
     },
     {
      "name": "ODAN-VALPROIC ACID"
     },
     {
      "name": "PMS-VALPROIC ACID"
     }
    ]
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": {
    "name": "Valproate (Valproic acid)",
    "cas": "99-66-1",
    "wiki": "https://en.wikipedia.org/wiki/Valproate",
    "atc": [
     "N03AG01"
    ],
    "names": {
     "inn": [
      "valproic acid"
     ],
     "inn_checked": {
      "status": "INN",
      "source": "ChEBI (CHEBI:39867) typed INN; corroborated by Fimea WHO cumulative list (also lists 'valproate semisodium' as a separate INN for the hemisodium salt)",
      "url": "https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:39867"
     },
     "languages": {
      "fr": [
       "acide valproïque",
       "valproate de sodium"
      ],
      "de": [
       "Valproinsäure"
      ],
      "es": [
       "ácido valproico"
      ],
      "it": [
       "acido valproico"
      ],
      "nl": [
       "valproïnezuur"
      ],
      "pt": [
       "valproato"
      ],
      "la": [
       "acidum valproicum"
      ]
     },
     "us_discontinued": [
      "Depacon",
      "Depakene",
      "Depakote Cp",
      "Stavzor"
     ],
     "wikidata": [
      "Q240642",
      "Q27261400",
      "Q4347890"
     ],
     "atc_codes": [
      "N03AG01"
     ],
     "snomed": [
      "13965000",
      "264325000",
      "387080000",
      "387481005",
      "433011000221103",
      "5641004"
     ],
     "eu_url": {},
     "eu_status": {},
     "it": [
      "ACIDO VALPROICO E SODIO VALPROATO EG",
      "ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM",
      "ACIDO VALPROICO SANDOZ",
      "DEPAKIN",
      "SODIO VALPROATO AUROBINDO",
      "SODIO VALPROATO AUROBINDO ITALIA",
      "SODIO VALPROATO SEACROSS"
     ],
     "es": [
      "ACIDO VALPROICO ALTAN",
      "ACIDO VALPROICO AUROVITAS",
      "ACIDO VALPROICO SEACROSS",
      "DEPAKINE",
      "DEPAKINE CRONO",
      "VALPROATO SODICO AUROVITAS"
     ],
     "ca": [
      "APO-DIVALPROEX",
      "APO-VALPROIC ACID",
      "DEPAKENE",
      "EPIVAL",
      "JAMP DIVALPROEX",
      "JAMP VALPROIC ACID ORAL SOLUTION",
      "MYLAN-DIVALPROEX",
      "ODAN-VALPROIC ACID",
      "PMS-VALPROIC ACID"
     ],
     "generic": [
      "calcium valproate",
      "divalproex sodium",
      "magnesium valproate",
      "sodium valproate"
     ],
     "us": [
      "Depakote",
      "Depakote Er"
     ],
     "eu": [],
     "fr": [
      "DEPAKINE",
      "DEPAKINE CHRONO",
      "DEPAKOTE",
      "DIVALCOTE",
      "MICROPAKINE L.P.",
      "VALPROATE DE SODIUM AGUETTANT",
      "VALPROATE DE SODIUM ARROW",
      "VALPROATE DE SODIUM ARROW L.P.",
      "VALPROATE DE SODIUM BIOGARAN L.P.",
      "VALPROATE DE SODIUM EG L.P.",
      "VALPROATE DE SODIUM TEVA SANTE L.P.",
      "VALPROATE DE SODIUM VIATRIS L.P."
     ],
     "rxcui": [
      "40254"
     ],
     "resolved_as": "RxNorm valproate + valproic acid",
     "read": "2026-10-03",
     "note": ""
    },
    "atc_list": [
     {
      "code": "N03AG01",
      "route": "systemic",
      "source": "RxNorm"
     }
    ],
    "url": "https://www.dysnet.org/knowledge/teratogens/?q=Valproate"
   },
   "register_name": "Valproate (Valproic acid)"
  },
  "isotretinoin": {
   "atc": "D10BA01",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-19591",
     "date": "2022-09-21",
     "motif": "Réévaluation suite saisine Ministères (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3377735",
     "products": [
      "PROCUTA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités orales à base d’isotrétinoïne (ACNETRAIT, CONTRACNE, CURACNE et PROCUTA) est important dans l’indication de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-19590",
     "date": "2022-09-21",
     "motif": "Réévaluation suite saisine Ministères (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3377738",
     "products": [
      "CURACNE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités orales à base d’isotrétinoïne (ACNETRAIT, CONTRACNE, CURACNE et PROCUTA) est important dans l’indication de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-19574",
     "date": "2022-09-21",
     "motif": "Réévaluation suite saisine Ministères (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3377744",
     "products": [
      "ISOTRETINOINE ACNETRAIT"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités orales à base d’isotrétinoïne (ACNETRAIT, CONTRACNE, CURACNE et PROCUTA) est important dans l’indication de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-19572",
     "date": "2022-09-21",
     "motif": "Réévaluation suite saisine Ministères (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3377741",
     "products": [
      "CONTRACNE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités orales à base d’isotrétinoïne (ACNETRAIT, CONTRACNE, CURACNE et PROCUTA) est important dans l’indication de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-15868",
     "date": "2017-02-08",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2754731",
     "products": [
      "PROCUTA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités PROCUTA reste important dans l’indication de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-14787",
     "date": "2016-05-25",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2637975",
     "products": [
      "CURACNE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par CURACNE reste important dans l’indication de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-14072",
     "date": "2015-07-01",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2047003",
     "products": [
      "ISOTRETINOINE ACNETRAIT"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités ACNETRAIT reste important dans l’indication de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-12522",
     "date": "2013-03-06",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_1367939",
     "products": [
      "CONTRACNE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités CONTRACNE reste important dans l’acné sévère."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-7496",
     "date": "2010-04-07",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "ISOTRETINOINE ACNETRAIT"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n'apporte pas d'amélioration du service médical rendu (ASMR V)."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "CONTRACNE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63918395/extrait",
      "products": 4
     },
     {
      "name": "CURACNE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62318935/extrait",
      "products": 4
     },
     {
      "name": "ISOTRETINOINE ACNETRAIT",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62121489/extrait",
      "products": 4
     },
     {
      "name": "PROCUTA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65250375/extrait",
      "products": 4
     },
     {
      "name": "ROACCUTANE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66296030/extrait",
      "products": 1
     }
    ],
    "ES": [
     {
      "name": "ACNEMIN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/82566/FT_82566.html",
      "products": 2,
      "atc": [
       "D10BA01"
      ]
     },
     {
      "name": "DERCUTANE",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65333/FT_65333.html",
      "products": 6,
      "atc": [
       "D10BA01"
      ]
     },
     {
      "name": "FLEXRESAN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66160/FT_66160.html",
      "products": 2,
      "atc": [
       "D10BA01"
      ]
     },
     {
      "name": "ISDIBEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66121/FT_66121.html",
      "products": 3,
      "atc": [
       "D10BA01"
      ]
     },
     {
      "name": "ISOACNE",
      "url": "https://cima.aemps.es/cima/dochtml/ft/67570/FT_67570.html",
      "products": 4,
      "atc": [
       "D10BA01"
      ]
     },
     {
      "name": "ISOTIORGA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/86648/FT_86648.html",
      "products": 2,
      "atc": [
       "D10BA01"
      ]
     },
     {
      "name": "MAYESTA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69571/FT_69571.html",
      "products": 2,
      "atc": [
       "D10BA01"
      ]
     }
    ],
    "UK": [],
    "IT": [
     {
      "name": "AISOSKIN"
     },
     {
      "name": "ISDIBEN"
     },
     {
      "name": "ISODIFA"
     },
     {
      "name": "ISORIAC"
     },
     {
      "name": "ISOTIORGA"
     },
     {
      "name": "ISOTRETINOINA DIFA"
     },
     {
      "name": "ISOTRETINOINA DIFA COOPER"
     },
     {
      "name": "NOIDAK"
     }
    ],
    "US": [
     {
      "name": "Absorica"
     },
     {
      "name": "Absorica Ld"
     },
     {
      "name": "Accutane"
     },
     {
      "name": "Amnesteem"
     },
     {
      "name": "Claravis"
     },
     {
      "name": "Myorisan"
     },
     {
      "name": "Sotret"
     },
     {
      "name": "Zenatane"
     }
    ],
    "US_discontinued": [],
    "CA": [
     {
      "name": "ABSORICA LD"
     },
     {
      "name": "ACCUTANE"
     },
     {
      "name": "CLARUS"
     },
     {
      "name": "EPURIS"
     }
    ]
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": {
    "name": "Isotretinoin",
    "cas": "4759-48-2",
    "wiki": "https://en.wikipedia.org/wiki/Isotretinoin",
    "atc": [
     "D10AD04",
     "D10BA01"
    ],
    "names": {
     "inn": [
      "isotretinoin"
     ],
     "inn_checked": {},
     "languages": {
      "fr": [
       "isotrétinoine"
      ],
      "es": [
       "isotretinoína"
      ],
      "it": [
       "isotretinoina"
      ],
      "nl": [
       "isotretinoïne"
      ],
      "pt": [
       "isotretinoína"
      ],
      "la": [
       "isotretinoinum"
      ]
     },
     "us_discontinued": [],
     "wikidata": [
      "Q287029"
     ],
     "atc_codes": [
      "D10AD04",
      "D10BA01"
     ],
     "snomed": [
      "38314008",
      "387208003"
     ],
     "eu_url": {},
     "eu_status": {},
     "it": [
      "AISOSKIN",
      "ISDIBEN",
      "ISODIFA",
      "ISORIAC",
      "ISOTIORGA",
      "ISOTRETINOINA DIFA",
      "ISOTRETINOINA DIFA COOPER",
      "NOIDAK"
     ],
     "es": [
      "ACNEMIN",
      "ACNISDIN",
      "DERCUTANE",
      "FLEXRESAN",
      "ISDIBEN",
      "ISOACNE",
      "ISOTIORGA",
      "MAYESTA"
     ],
     "ca": [
      "ABSORICA LD",
      "ACCUTANE",
      "CLARUS",
      "EPURIS"
     ],
     "generic": [],
     "us": [
      "Absorica",
      "Absorica Ld",
      "Accutane",
      "Amnesteem",
      "Claravis",
      "Myorisan",
      "Sotret",
      "Zenatane"
     ],
     "eu": [],
     "fr": [
      "CONTRACNE",
      "CURACNE",
      "ISOTRETINOINE ACNETRAIT",
      "PROCUTA",
      "ROACCUTANE"
     ],
     "rxcui": [
      "6064"
     ],
     "resolved_as": "RxNorm IN",
     "read": "2026-10-03",
     "note": ""
    },
    "atc_list": [
     {
      "code": "D10BA01",
      "route": "systemic",
      "source": "RxNorm"
     },
     {
      "code": "D10AD04",
      "route": "skin",
      "source": "RxNorm"
     }
    ],
    "url": "https://www.dysnet.org/knowledge/teratogens/?q=Isotretinoin"
   },
   "register_name": "Isotretinoin"
  },
  "methotrexate": {
   "atc": "L04AX03",
   "epar": [
    {
     "name": "Jylamvo",
     "number": "EMEA/H/C/003756",
     "status": "Authorised",
     "inn": "methotrexate",
     "substance": "methotrexate",
     "atc": [
      "L04AX03"
     ],
     "holder": "Oresund Pharma ApS",
     "generic": false,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2017-03-29",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-09-07",
     "therapeutic_area": "Arthritis, Psoriatic;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Psoriasis;Arthritis, Rheumatoid;Arthritis",
     "indication": "In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jylamvo"
    },
    {
     "name": "Nordimet",
     "number": "EMEA/H/C/003983",
     "status": "Authorised",
     "inn": "methotrexate",
     "substance": "methotrexate",
     "atc": [
      "L04AX03"
     ],
     "holder": "Nordic Group B.V.",
     "generic": false,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2016-08-18",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-09-07",
     "therapeutic_area": "Arthritis, Psoriatic;Psoriasis;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid",
     "indication": "Nordimet is indicated for the treatment of: active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nordimet"
    }
   ],
   "has_ct": [
    {
     "dossier": "CT-21230",
     "date": "2025-03-12",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3598812",
     "products": [
      "NORDIMET"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par NORDIMET 7,5 mg, 10 mg, 12,5 mg, 15 mg, 17,5 mg, 20 mg, 22,5 mg et 25 mg (méthotrexate), solution injectable en stylo prérempli, est important dans l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "La commission de la Transparence considère que NORDIMET 7,5 mg, 10 mg, 12,5 mg, 15 mg, 17,5 mg, 20 mg, 22,5 mg et 25 mg (méthotrexate), solution injectable en stylo prérempli, n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie de prise en charge du psoriasis en plaques modéré chez les patients adultes candidats à un traitement systémique par rapport aux autres spécialités à base de méthotrexate."
      }
     ]
    },
    {
     "dossier": "CT-20219",
     "date": "2023-04-26",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3434166",
     "products": [
      "IMENOR"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par METHOTREXATE ORION 10 mg (méthotrexate), comprimé, est important dans :\n• la polyarthrite rhumatoïde active chez les patients adultes,\n• le psoriasis récalcitrant sévère invalidant ne répondant pas de manière adéquate aux autres formes de traitement telles que la photothérapie, la puvathérapie et aux rétinoïdes, et rhumatisme psoriasique sévère chez les patients adultes,\n• le traitement d’entretien des leucémies aiguës lymphoblastiques chez l’adulte, l’adolescent et l’enfant à partir de 3 ans."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport à la présentation déjà inscrite."
      }
     ]
    },
    {
     "dossier": "CT-19975",
     "date": "2022-10-05",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3382729",
     "products": [
      "METOTAB"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par METOTAB (méthotrexate) 2,5 mg, comprimé et METOTAB (mé-thotrexate) 10 mg, comprimé sécable est important dans :\n• la polyarthrite rhumatoïde active chez les patients adultes .\n• le psoriasis récalcitrant sévère invalidant ne répondant pas de manière adéquate aux autres formes de traitement telles que la photothérapie, la puvathérapie et aux réti-noïdes, et rhumatisme psoriasique sévère chez les patients adultes .\n• le traitement d’entretien des leucémies aiguës lymphoblastiques."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un eurogénérique qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux spécialités à base de méthotrexate déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-19772",
     "date": "2022-07-06",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3358603",
     "products": [
      "NORDIMET"
     ],
     "smr": [
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par NORDIMET (méthotrexate) est jugé insuffisant pour justifier une prise en charge par la solidarité nationale au regard des alterna-tives disponibles concernant les patients non réfractaires ou tolérants aux thiopurines"
      },
      {
       "value": "Modéré",
       "label": "Le service médical rendu par NORDIMET (méthotrexate) est modéré dans le traitement de l’induction d’une rémission lors de la maladie de Crohn modérée dépendante des stéroïdes chez les patients adultes réfractaires ou intolérants aux thiopurines, en association avec des corti-costéroïdes, et le maintien de la rémission, en monothérapie, chez les patients adultes ayant répon-du au méthotrexate."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "NORDIMET 25 mg/mL, solution injectable en stylo prérempli (méthotrexate) n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie de prise en charge chez l’adulte de la maladie de Crohn par rapport aux autres spécialités à base de méthotrexate."
      }
     ]
    },
    {
     "dossier": "CT-19771",
     "date": "2022-07-06",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3358600",
     "products": [
      "IMETH"
     ],
     "smr": [
      {
       "value": "Modéré",
       "label": "Le service médical rendu par IMETH (méthotrexate) est modéré dans les formes légères à modérées de la maladie de Crohn, utilisé seul ou en association avec des corticostéroïdes, chez les patients adultes réfractaires ou intolérants aux thiopurines."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "IMETH (méthotrexate) n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres spécialités à base de méthotrexate déjà inscrites dans cette extension d’indication (maladie de Crohn)."
      }
     ]
    },
    {
     "dossier": "CT-19690",
     "date": "2022-02-09",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3317076",
     "products": [
      "IZIXATE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par IZIXATE (méthotrexate) est important :\n• dans la polyarthrite rhumatoïde active chez l’adulte .\n• dans les formes polyarticulaires de l’arthrite juvénile idiopathique active sévère, en cas de réponse inadéquate aux anti-inflammatoires non stéroïdiens (AINS) .\n• dans le psoriasis récalcitrant sévère invalidant de l’adulte, ne répondant pas suffisamment à d’autres types de thérapie telles que la photothérapie, la puvathérapie et les rétinoïdes .\n• dans les formes sévères du rhumatisme psoriasique chez l'adulte."
      },
      {
       "value": "Modéré",
       "label": "Le service médical rendu par IZIXATE (méthotrexate) est modéré dans les formes légères à modérées de la maladie de Crohn, seul ou en association avec des corticostéroïdes, chez les patients adultes réfractaires ou intolérants aux thiopurines."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des spécialités hybrides qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport à la spécialité de référence."
      }
     ]
    },
    {
     "dossier": "CT-19683",
     "date": "2022-01-19",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3315488",
     "products": [
      "IMENOR"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par METHOTREXATE ORION 10 mg, comprimé, est important dans :\n• La polyarthrite rhumatoïde active chez les patients adultes.\n• Le psoriasis récalcitrant sévère invalidant ne répondant pas de manière adéquate aux autres formes de traitement telles que la photothérapie, la puvathérapie et aux rétinoïdes, et rhumatisme psoriasique sévère chez les patients adultes.\n• Le traitement d’entretien des leucémies aiguës lymphoblastiques"
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un eurogénérique qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux spécialités à base de méthotrexate déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-19592",
     "date": "2022-01-05",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3314510",
     "products": [
      "NOVATREX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par NOVATREX (méthotrexate) est important dans la leucémie aigüe lymphoblastique (LAL) en traitement d’entretien chez les adultes, enfants et adolescents."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux spécialités à base de méthotrexate déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-18857",
     "date": "2020-11-18",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3219449",
     "products": [
      "METHOTREXATE ACCORD"
     ],
     "smr": [
      {
       "value": "Modéré",
       "label": "Le service médical rendu par METHOTREXATE ACCORD 50 mg/mL, solution injectable en seringue préremplie est modéré dans cette indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "La commission de la Transparence considère que METHOTREXATE ACCORD 50 mg/mL, solution injectable en seringue préremplie n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie de prise en charge de la maladie de Crohn comme la spécialité de référence, METOJECT 25 mg/0,5 mL solution injectable."
      }
     ]
    },
    {
     "dossier": "CT-18044",
     "date": "2020-02-05",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3159947",
     "products": [
      "METOJECT"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par METOJECT (méthotrexate) est important dans le traitement des formes modérées de psoriasis chez les adultes candidats à un traitement systémique et aux posologies de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Compte tenu :\n• de la démonstration de la supériorité du méthotrexate injectable par rapport au placebo chez des patients adultes ayant un psoriasis modéré à sévère en termes de pourcentage de répondeurs PASI 75, candidats à un traitement systémique,\n• de l’absence de comparaison à d’autres traitements systémiques de 1ère intention,\nla Commission de la transparence considère que METOJECT (méthotrexate) n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres traitement systémiques de 1ère intention dans la prise en charge des formes modérées du psoriasis chez les adultes candidats à un traitement systémique."
      }
     ]
    },
    {
     "dossier": "CT-17937",
     "date": "2020-02-05",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3151141",
     "products": [
      "METHOTREXATE ACCORD"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par METHOTREXATE ACCORD 2,5 mg, comprimé, et METHOTREXATE ACCORD 10 mg, comprimé, est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Les spécialités METHOTREXATE ACCORD 2,5 mg, comprimé, et METHOTREXATE ACCORD 10 mg, comprimé, n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux spécialités à base de méthotrexate déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-17579",
     "date": "2019-11-06",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3121601",
     "products": [
      "METOJECT"
     ],
     "smr": [
      {
       "value": "Modéré",
       "label": "Le service médical rendu par METOJECT est modéré dans l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Compte tenu :\n• de la démonstration de la supériorité du méthotrexate par rapport au placebo chez des patients adultes ayant une maladie de Crohn légère à modérée, active malgré l’utilisation de corticoïdes, avec un niveau de preuve modéré .\n• de l’absence de donnée d’efficacité dans la population correspondant à l’AMM de METOJECT à savoir les patients en échec à une thiopurine .\n• de l’absence de donnée versus un traitement actif : 6-mercaptopurine (hors AMM) dans les formes légères et surtout un anti-TNF dans les formes modérées après échec d’au moins un immunosuppresseur .\n• du profil de tolérance du méthotrexate avec notamment des troubles digestifs gênants conduisant les patients à arrêter le traitement .\n\nla commission de la Transparence considère que METOJECT n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie de prise en charge de la maladie de Crohn."
      }
     ]
    },
    {
     "dossier": "CT-16660",
     "date": "2018-12-12",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2896738",
     "products": [
      "METOJECT"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par METOJECT reste important dans les indications et aux posologies de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-17091",
     "date": "2018-09-05",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2870213",
     "products": [
      "PREXATE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "le service médical rendu par les spécialités PREXATE solution injectable en seringue préremplie est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport à METOJECT."
      }
     ]
    },
    {
     "dossier": "CT-16735",
     "date": "2018-01-24",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2824467",
     "products": [
      "METHOTREXATE ACCORD"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par METHOTREXATE ACCORD 25 mg/mL, solution injectable et par METHOTREXATE ACCORD 100 mg/mL, solution injectable est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport à LEDERTREXATE 50 mg/ 2 ml solution injectable."
      }
     ]
    },
    {
     "dossier": "CT-16713",
     "date": "2018-01-24",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2824798",
     "products": [
      "METHOTREXATE ACCORD"
     ],
     "smr": [
      {
       "value": "Commentaires",
       "label": "En absence de donnée clinique et d’évaluation de la spécialité de référence METOJECT, la Commission ne peut se prononcer sur le service médical rendu par METHOTREXATE ACCORD 50 mg/ml dans l’indication suivante : traitement dans la maladie de Crohn légère à modérée seule ou en association avec des corticostéroïdes chez les patients adultes intolérants ou réfractaires aux thiopurines."
      },
      {
       "value": "Important",
       "label": "Le service médical rendu par METHOTREXATE ACCORD 50 mg/ml, solution injectable en seringue préremplie est important dans les indications de l’AMM identiques à celles déjà inscrites de METOJECT, à savoir :\n• traitement de la polyarthrite rhumatoïde sévère et active de l’adulte,\n• traitement des formes polyarticulaires actives et sévères de l’arthrite idiopathique juvénile en cas de réponse inadéquate aux anti-inflammatoires non stéroïdiens (AINS),\n• traitement du psoriasis récalcitrant sévère invalidant de l’adulte ne répondant pas de manière adéquate aux autres formes de traitement telles que la photothérapie, la PUVAthérapie et les rétinoïdes et\n• du rhumatisme psoriasique de l'adulte en cas de non réponse aux traitements conventionnels. »"
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à METOJECT."
      }
     ]
    },
    {
     "dossier": "CT-16653",
     "date": "2018-01-10",
     "motif": "Extension d'indication non sollicitée",
     "url": "https://www.has-sante.fr/jcms/c_2820671",
     "products": [
      "IMETH"
     ],
     "smr": [
      {
       "value": "Non précisé",
       "label": "La Commission prend acte du fait que le laboratoire ne demande pas l’inscription des spécialités IMETH dans cette indication et rappelle que de ce fait ces spécialités ne sont pas remboursables et ne sont pas agréées aux collectivités dans l’indication : « traitement des formes légères à modérées de la maladie de Crohn, utilisé seul ou en association aux corticostéroïdes, chez les patients adultes réfractaires ou intolérants aux thiopurines »."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-15568",
     "date": "2017-01-25",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2744490",
     "products": [
      "NOVATREX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par NOVATREX 2,5 mg reste important dans le psoriasis de l'adulte :\n• psoriasis en grandes plaques, étendu et résistant aux thérapeutiques classiques (puvathérapie, rétinoïdes),\n• érythrodermie psoriasique,\n• psoriasis pustuleux généralisé,\net dans la polyarthrite rhumatoïde."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-15735",
     "date": "2016-11-30",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2730809",
     "products": [
      "NORDIMET"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités NORDIMET est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux spécialités IMETH."
      }
     ]
    },
    {
     "dossier": "CT-15619",
     "date": "2016-10-05",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2678865",
     "products": [
      "NOVATREX"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-14630",
     "date": "2016-04-06",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2625120",
     "products": [
      "METHOTREXATE BIODIM"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu de la gamme METHOTREXATE BIODIM/LEDERTREXATE, solution injectable, reste important dans les indications de rhumatologie, de dermatologie et d’oncologie sauf dans les adénocarcinomes ovariens et les carcinomes bronchiques à petites cellules."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu de la gamme METHOTREXATE BIODIM/LEDERTREXATE est insuffisant dans les adénocarcinomes ovariens et les carcinomes bronchiques à petites cellules."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-15076",
     "date": "2016-03-16",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2620156",
     "products": [
      "METOJECT"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres présentations de METOJECT déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-14482",
     "date": "2015-10-07",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2563033",
     "products": [
      "IMETH"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités IMETH solution injectable en seringue pré-remplie est important dans :\n• le traitement de la polyarthrite rhumatoïde et de l’arthrite idiopathique juvénile,\n• le traitement du rhumatisme psoriasique,\n• le traitement du psoriasis sévère."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Dans l’ensemble des indications de l’AMM, les spécialités IMETH solution injectable en seringue pré-remplie n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux spécialités METOJECT solution injectable en seringue pré-remplie."
      }
     ]
    },
    {
     "dossier": "CT-14358",
     "date": "2015-10-07",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2563012",
     "products": [
      "IMETH"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par IMETH reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-14140",
     "date": "2015-04-01",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2031566",
     "products": [
      "IMETH"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V)."
      }
     ]
    },
    {
     "dossier": "CT-12720",
     "date": "2013-02-06",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "METOJECT"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V, inexistante) par rapport à la présentation déjà inscrite (METOJECT 10 mg/ml)."
      }
     ]
    },
    {
     "dossier": "CT-8293",
     "date": "2010-06-16",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "IMETH"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités n'apportent pas d'amélioration du service médical rendu (ASMR V) par rapport aux autres spécialités à base de méthotrexate administrées par voie orale."
      }
     ]
    },
    {
     "dossier": "CT-7258",
     "date": "2009-11-18",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_893158",
     "products": [
      "METHOTREXATE BIODIM"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Dans le traitement de la polyarthrite rhumatoïde, l'arthropathie idiopathique juvénile, le rhumatisme psoriasique et le psoriasis, les spécialités injectables LEDERTREXATE n'apportent pas d'amélioration du service médical rendu (ASMR V) par rapport aux autres spécialités injectables à base de méthotrexate notamment les spécialités METHOTREXATE BELLON."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [
     {
      "name": "Jylamvo",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/jylamvo",
      "status": "Authorised",
      "kind": "reference"
     },
     {
      "name": "Nordimet",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/nordimet",
      "status": "Authorised",
      "kind": "reference"
     }
    ],
    "FR": [
     {
      "name": "IMENOR",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65787731/extrait",
      "products": 2
     },
     {
      "name": "IMETH",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65415275/extrait",
      "products": 8
     },
     {
      "name": "IZIXATE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66035589/extrait",
      "products": 10
     },
     {
      "name": "METHOTREXATE ACCORD",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60390455/extrait",
      "products": 5
     },
     {
      "name": "METHOTREXATE TEVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67301605/extrait",
      "products": 4
     },
     {
      "name": "METHOTREXATE VIATRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67217445/extrait",
      "products": 4
     },
     {
      "name": "METOJECT",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64768062/extrait",
      "products": 15
     },
     {
      "name": "METOTAB",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62537295/extrait",
      "products": 2
     },
     {
      "name": "NORDIMET",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67311325/extrait",
      "products": 8
     },
     {
      "name": "NOVATREX",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67853564/extrait",
      "products": 1
     }
    ],
    "ES": [
     {
      "name": "BERTANEL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/71400/FT_71400.html",
      "products": 6,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "IMETH",
      "url": "https://cima.aemps.es/cima/dochtml/ft/79580/FT_79580.html",
      "products": 8,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "JIAX SEMANAL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/82778/FT_82778.html",
      "products": 1,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "METHOFILL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/80861/FT_80861.html",
      "products": 20,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "METHOFILL PEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/85485/FT_85485.html",
      "products": 10,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "METOJECT",
      "url": "https://cima.aemps.es/cima/dochtml/ft/71108/FT_71108.html",
      "products": 19,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "METOJECT PEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/78632/FT_78632.html",
      "products": 11,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "METOTREXATO SEMANAL CIPLA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/79758/FT_79758.html",
      "products": 1,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "METOTREXATO SEMANAL ORION PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/86492/FT_86492.html",
      "products": 2,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "NORDIMET",
      "url": "https://cima.aemps.es/cima/dochtml/ft/1161124002/FT_1161124002.html",
      "products": 12,
      "atc": [
       "L04AX03"
      ]
     },
     {
      "name": "QUINUX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/79126/FT_79126.html",
      "products": 10,
      "atc": [
       "L04AX03"
      ]
     }
    ],
    "UK": [],
    "IT": [
     {
      "name": "AFSLAMET"
     },
     {
      "name": "IMMUTREX"
     },
     {
      "name": "METHOTREXATE"
     },
     {
      "name": "METOTHER"
     },
     {
      "name": "METOTRESSATO TEVA"
     },
     {
      "name": "METOTREXATO AUROBINDO"
     },
     {
      "name": "METOTREXATO DOC GENERICI"
     },
     {
      "name": "METOTREXATO MYLAN"
     },
     {
      "name": "NORDIMET"
     },
     {
      "name": "REUMAFLEX"
     },
     {
      "name": "TREXOTHER"
     },
     {
      "name": "VELOS"
     }
    ],
    "US": [
     {
      "name": "Jylamvo"
     },
     {
      "name": "Methotrexate Preservative Free"
     },
     {
      "name": "Methotrexate Sodium Preservative Free"
     },
     {
      "name": "Otrexup"
     },
     {
      "name": "Rasuvo"
     },
     {
      "name": "Reditrex"
     },
     {
      "name": "Trexall"
     },
     {
      "name": "Xatmep"
     }
    ],
    "US_discontinued": [
     {
      "name": "Abitrexate"
     },
     {
      "name": "Folex"
     },
     {
      "name": "Folex Pfs"
     },
     {
      "name": "Methotrexate Lpf"
     },
     {
      "name": "Mexate"
     },
     {
      "name": "Mexate-Aq"
     },
     {
      "name": "Mexate-Aq Preserved"
     },
     {
      "name": "Otrexup Pfs"
     }
    ],
    "CA": [
     {
      "name": "ACH-METHOTREXATE"
     },
     {
      "name": "APO-METHOTREXATE"
     },
     {
      "name": "AURO-METHOTREXATE"
     },
     {
      "name": "JAMP METHOTREXATE TABLETS"
     },
     {
      "name": "M-METHOTREXATE"
     },
     {
      "name": "METHOFILL SELF-DOSE INJECTOR"
     },
     {
      "name": "METHOTREXATE INJECTION"
     },
     {
      "name": "METHOTREXATE INJECTION BP"
     },
     {
      "name": "METHOTREXATE INJECTION USP"
     },
     {
      "name": "METHOTREXATE SODIUM INJECTION"
     },
     {
      "name": "METHOTREXATE SUBCUTANEOUS"
     },
     {
      "name": "METHOTREXATE TABLETS"
     },
     {
      "name": "METOJECT SUBCUTANEOUS"
     },
     {
      "name": "PMS-METHOTREXATE"
     },
     {
      "name": "PMS-METHOTREXATE INJECTION"
     },
     {
      "name": "PMS-METHOTREXATE TABLETS"
     }
    ]
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": {
    "name": "Methotrexate",
    "cas": "59-05-2",
    "wiki": "https://en.wikipedia.org/wiki/Methotrexate",
    "atc": [
     "L01BA01",
     "L04AX03"
    ],
    "names": {
     "inn": [
      "methotrexate"
     ],
     "inn_checked": {},
     "languages": {
      "fr": [
       "méthotrexate"
      ],
      "es": [
       "metotrexato"
      ],
      "it": [
       "metotrexato"
      ],
      "nl": [
       "methotrexaat"
      ],
      "pt": [
       "metotrexato"
      ],
      "la": [
       "methotrexatum"
      ]
     },
     "us_discontinued": [
      "Abitrexate",
      "Folex",
      "Folex Pfs",
      "Methotrexate Lpf",
      "Mexate",
      "Mexate-Aq",
      "Mexate-Aq Preserved",
      "Otrexup Pfs"
     ],
     "wikidata": [
      "Q422232"
     ],
     "atc_codes": [
      "L01BA01",
      "L04AX03"
     ],
     "snomed": [
      "387381009",
      "412247000",
      "68887009"
     ],
     "eu_url": {
      "Nordimet": "https://www.ema.europa.eu/en/medicines/human/EPAR/nordimet",
      "Jylamvo": "https://www.ema.europa.eu/en/medicines/human/EPAR/jylamvo"
     },
     "eu_status": {
      "Nordimet": "Authorised",
      "Jylamvo": "Authorised"
     },
     "it": [
      "AFSLAMET",
      "IMMUTREX",
      "METHOTREXATE",
      "METOTHER",
      "METOTRESSATO TEVA",
      "METOTREXATO AUROBINDO",
      "METOTREXATO DOC GENERICI",
      "METOTREXATO MYLAN",
      "NORDIMET",
      "REUMAFLEX",
      "TREXOTHER",
      "VELOS"
     ],
     "es": [
      "BERTANEL",
      "IMETH",
      "JIAX SEMANAL",
      "METHOFILL",
      "METHOFILL PEN",
      "METOJECT",
      "METOJECT PEN",
      "METOTREXATO ACCORD",
      "METOTREXATO PFIZER",
      "METOTREXATO SEMANAL CIPLA",
      "METOTREXATO SEMANAL ORION PHARMA",
      "METOTREXATO SEMANAL WYETH",
      "METOTREXATO WYETH",
      "NORDIMET",
      "QUINUX"
     ],
     "ca": [
      "ACH-METHOTREXATE",
      "APO-METHOTREXATE",
      "AURO-METHOTREXATE",
      "JAMP METHOTREXATE TABLETS",
      "M-METHOTREXATE",
      "METHOFILL SELF-DOSE INJECTOR",
      "METHOTREXATE INJECTION",
      "METHOTREXATE INJECTION BP",
      "METHOTREXATE INJECTION USP",
      "METHOTREXATE SODIUM INJECTION",
      "METHOTREXATE SUBCUTANEOUS",
      "METHOTREXATE TABLETS",
      "METOJECT SUBCUTANEOUS",
      "PMS-METHOTREXATE",
      "PMS-METHOTREXATE INJECTION",
      "PMS-METHOTREXATE TABLETS"
     ],
     "generic": [
      "methotrexate sodium"
     ],
     "us": [
      "Jylamvo",
      "Methotrexate Preservative Free",
      "Methotrexate Sodium Preservative Free",
      "Otrexup",
      "Rasuvo",
      "Reditrex",
      "Trexall",
      "Xatmep"
     ],
     "eu": [
      "Jylamvo",
      "Nordimet"
     ],
     "fr": [
      "IMENOR",
      "IMETH",
      "IZIXATE",
      "METHOTREXATE ACCORD",
      "METHOTREXATE BIODIM",
      "METHOTREXATE TEVA",
      "METHOTREXATE VIATRIS",
      "METOJECT",
      "METOTAB",
      "NORDIMET",
      "NOVATREX"
     ],
     "rxcui": [
      "6851"
     ],
     "resolved_as": "RxNorm IN",
     "read": "2026-10-03",
     "note": ""
    },
    "atc_list": [
     {
      "code": "L01BA01",
      "route": "systemic",
      "source": "RxNorm"
     },
     {
      "code": "L04AX03",
      "route": "systemic",
      "source": "RxNorm"
     }
    ],
    "url": "https://www.dysnet.org/knowledge/teratogens/?q=Methotrexate"
   },
   "register_name": "Methotrexate"
  },
  "lithium": {
   "atc": "N05AN01",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-14569",
     "date": "2016-03-02",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2617880",
     "products": [
      "TERALITHE",
      "TERALITHE LP"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par TERALITHE reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "TERALITHE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62124478/extrait",
      "products": 1
     },
     {
      "name": "TERALITHE LP",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67292476/extrait",
      "products": 1
     }
    ],
    "ES": [
     {
      "name": "PLENUR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/48932/FT_48932.html",
      "products": 1,
      "atc": [
       "N05AN01"
      ]
     }
    ],
    "UK": [],
    "IT": [
     {
      "name": "CARBOLITHIUM"
     },
     {
      "name": "LITIO CARBONATO L.F.M."
     },
     {
      "name": "LITIO CARBONATO NOVA ARGENTIA"
     },
     {
      "name": "RESILIENT"
     }
    ],
    "US": [
     {
      "name": "Lithobid"
     }
    ],
    "US_discontinued": [
     {
      "name": "Eskalith"
     },
     {
      "name": "Eskalith Cr"
     },
     {
      "name": "Lithane"
     },
     {
      "name": "Lithonate"
     },
     {
      "name": "Lithotabs"
     }
    ],
    "CA": [
     {
      "name": "APO-LITHIUM CARBONATE"
     },
     {
      "name": "CARBOLITH"
     },
     {
      "name": "LITHANE"
     },
     {
      "name": "LITHMAX"
     },
     {
      "name": "PMS-LITHIUM CARBONATE"
     }
    ]
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": {
    "name": "Lithium carbonate",
    "cas": "554-13-2",
    "wiki": "https://en.wikipedia.org/wiki/Lithium_carbonate",
    "names": {
     "inn": [],
     "inn_checked": {
      "status": "no INN",
      "source": "ChEBI (CHEBI:6504) \"Lithium carbonate\" listed only as SYNONYM/IUPAC NAME, no INN-type entry; absent from Fimea WHO cumulative INN list",
      "url": "https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:6504"
     },
     "languages": {
      "fr": [
       "carbonate de lithium"
      ],
      "de": [
       "Lithiumcarbonat"
      ],
      "es": [
       "Carbonato de litio"
      ],
      "it": [
       "Carbonato di litio"
      ],
      "nl": [
       "lithiumcarbonaat"
      ],
      "pt": [
       "carbonato de lítio"
      ]
     },
     "us_discontinued": [
      "Eskalith",
      "Eskalith Cr",
      "Lithane",
      "Lithonate",
      "Lithotabs"
     ],
     "wikidata": [
      "Q410174"
     ],
     "atc_codes": [
      "N05AN01"
     ],
     "snomed": [
      "16977003",
      "387095003"
     ],
     "eu_url": {},
     "eu_status": {},
     "it": [
      "CARBOLITHIUM",
      "LITIO CARBONATO L.F.M.",
      "LITIO CARBONATO NOVA ARGENTIA",
      "RESILIENT"
     ],
     "es": [
      "PLENUR"
     ],
     "ca": [
      "APO-LITHIUM CARBONATE",
      "CARBOLITH",
      "LITHANE",
      "LITHMAX",
      "PMS-LITHIUM CARBONATE"
     ],
     "generic": [],
     "us": [
      "Lithobid"
     ],
     "eu": [],
     "fr": [
      "GRANIONS DE LITHIUM",
      "LITHIODERM",
      "LITHIUM OLIGOSOL",
      "TERALITHE",
      "TERALITHE LP"
     ],
     "rxcui": [
      "42351"
     ],
     "resolved_as": "RxNorm IN",
     "read": "2026-10-03",
     "note": ""
    },
    "atc_list": [
     {
      "code": "N05AN01",
      "route": "systemic",
      "source": "RxNorm"
     }
    ],
    "url": "https://www.dysnet.org/knowledge/teratogens/?q=Lithium%20carbonate"
   },
   "register_name": "Lithium carbonate"
  },
  "warfarin": {
   "atc": "B01AA03",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-16065",
     "date": "2018-01-24",
     "motif": "Réévaluation SMR et ASMR",
     "url": "https://www.has-sante.fr/jcms/c_2826830",
     "products": [
      "COUMADINE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par COUMADINE reste important :\n• en prévention des complications thromboemboliques en rapport avec une FANV,\n• dans le traitement des TVP et EP et la prévention de leurs récidives, en relais de l’héparine."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Au regard des données disponibles, la Commission considère que COUMADINE n’apporte pas d’amélioration du service médical rendu (ASMR V) :\n• dans la stratégie thérapeutique de prévention des complications thromboemboliques en rapport avec la FANV qui comprend les AVK et les anticoagulants non-AVK,\n• dans la stratégie thérapeutique de traitement de la thrombose veineuse profonde (TVP) et de l’embolie pulmonaire (EP) et la prévention de la récidive de TVP et d’EP chez l’adulte, qui comprend les AVK et les anticoagulants oraux non-AVK."
      }
     ]
    },
    {
     "dossier": "CT-10032",
     "date": "2012-02-01",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_1216853",
     "products": [
      "COUMADINE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par ces spécialités reste important dans les indications de l'AMM."
      }
     ],
     "asmr": []
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "COUMADINE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64631925/extrait",
      "products": 3
     }
    ],
    "ES": [
     {
      "name": "ALDOCUMAR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/32864/FT_32864.html",
      "products": 4,
      "atc": [
       "B01AA03"
      ]
     }
    ],
    "UK": [],
    "IT": [
     {
      "name": "COUMADIN"
     }
    ],
    "US": [
     {
      "name": "Coumadin"
     },
     {
      "name": "Jantoven"
     }
    ],
    "US_discontinued": [
     {
      "name": "Athrombin"
     },
     {
      "name": "Athrombin-K"
     },
     {
      "name": "Panwarfin"
     }
    ],
    "CA": [
     {
      "name": "APO-WARFARIN"
     },
     {
      "name": "TARO-WARFARIN"
     }
    ]
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": {
    "name": "Warfarin",
    "cas": "81-81-2",
    "wiki": "https://en.wikipedia.org/wiki/Warfarin",
    "names": {
     "inn": [
      "warfarin"
     ],
     "inn_checked": {},
     "languages": {
      "fr": [
       "warfarine"
      ],
      "es": [
       "warfarina"
      ],
      "nl": [
       "Warfarine"
      ],
      "pt": [
       "Varfarina"
      ],
      "la": [
       "warfarinum"
      ]
     },
     "us_discontinued": [
      "Athrombin",
      "Athrombin-K",
      "Panwarfin"
     ],
     "wikidata": [
      "Q113368879"
     ],
     "atc_codes": [
      "B01AA03"
     ],
     "snomed": [
      "372756006",
      "41509001",
      "48603004",
      "63167009"
     ],
     "eu_url": {},
     "eu_status": {},
     "it": [
      "COUMADIN"
     ],
     "es": [
      "ALDOCUMAR"
     ],
     "ca": [
      "APO-WARFARIN",
      "TARO-WARFARIN"
     ],
     "generic": [
      "warfarin potassium",
      "warfarin sodium"
     ],
     "us": [
      "Coumadin",
      "Jantoven"
     ],
     "eu": [],
     "fr": [
      "COUMADINE"
     ],
     "rxcui": [
      "11289"
     ],
     "resolved_as": "RxNorm IN",
     "read": "2026-10-03",
     "note": ""
    },
    "atc_list": [
     {
      "code": "B01AA03",
      "route": "systemic",
      "source": "RxNorm"
     }
    ],
    "url": "https://www.dysnet.org/knowledge/teratogens/?q=Warfarin"
   },
   "register_name": "Warfarin"
  },
  "topiramate": {
   "atc": "N03AX11",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-16155",
     "date": "2017-09-27",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2797158",
     "products": [
      "EPITOMAX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par EPITOMAX reste important en prophylaxie de la migraine et dans le traitement de l’épilepsie, y compris des crises associées au syndrome de Lennox-Gastaut."
      }
     ],
     "asmr": []
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "EPITOMAX",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61913385/extrait",
      "products": 6
     },
     {
      "name": "TOPIRAMATE ARROW LAB",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64696702/extrait",
      "products": 3
     },
     {
      "name": "TOPIRAMATE SANDOZ",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68353836/extrait",
      "products": 2
     },
     {
      "name": "TOPIRAMATE VIATRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66961409/extrait",
      "products": 3
     }
    ],
    "ES": [
     {
      "name": "ACOMICIL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69661/FT_69661.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPAMAX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/61875/FT_61875.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPAMAX DISPERSABLE",
      "url": "https://cima.aemps.es/cima/dochtml/ft/63957/FT_63957.html",
      "products": 3,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO AUROVITAS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/84609/FT_84609.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO CINFA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69137/FT_69137.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO KERN PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68723/FT_68723.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO NORMON",
      "url": "https://cima.aemps.es/cima/dochtml/ft/70765/FT_70765.html",
      "products": 5,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO PENSA PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69425/FT_69425.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO PHARMA COMBIX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/73765/FT_73765.html",
      "products": 3,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO QUALIGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/70890/FT_70890.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO RATIOPHARM",
      "url": "https://cima.aemps.es/cima/dochtml/ft/67991/FT_67991.html",
      "products": 5,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO SANDOZ",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69177/FT_69177.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO TECNIGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/70646/FT_70646.html",
      "products": 3,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO VIATRIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69036/FT_69036.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     },
     {
      "name": "TOPIRAMATO STADA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68593/FT_68593.html",
      "products": 4,
      "atc": [
       "N03AX11"
      ]
     }
    ],
    "UK": [],
    "IT": [
     {
      "name": "TOPAMAX"
     },
     {
      "name": "TOPIRAMATO AUROBINDO"
     },
     {
      "name": "TOPIRAMATO DOC GENERICI"
     },
     {
      "name": "TOPIRAMATO EG"
     },
     {
      "name": "TOPIRAMATO MYLAN GENERICS"
     },
     {
      "name": "TOPIRAMATO SANDOZ"
     },
     {
      "name": "XITOP"
     }
    ],
    "US": [
     {
      "name": "Eprontia"
     },
     {
      "name": "Qsymia"
     },
     {
      "name": "Qudexy"
     },
     {
      "name": "Qudexy Xr"
     },
     {
      "name": "Topamax"
     },
     {
      "name": "Trokendi"
     },
     {
      "name": "Trokendi Xr"
     }
    ],
    "US_discontinued": [
     {
      "name": "Topamax Sprinkle"
     }
    ],
    "CA": [
     {
      "name": "AG-TOPIRAMATE TABLETS"
     },
     {
      "name": "APO-TOPIRAMATE"
     },
     {
      "name": "AURO-TOPIRAMATE"
     },
     {
      "name": "GLN-TOPIRAMATE"
     },
     {
      "name": "JAMP TOPIRAMATE TABLETS"
     },
     {
      "name": "MINT-TOPIRAMATE"
     },
     {
      "name": "MYLAN-TOPIRAMATE"
     },
     {
      "name": "NRA-TOPIRAMATE"
     },
     {
      "name": "PMS-TOPIRAMATE"
     },
     {
      "name": "PRO-TOPIRAMATE"
     },
     {
      "name": "TEVA-TOPIRAMATE"
     },
     {
      "name": "TOPAMAX"
     },
     {
      "name": "TOPIRAMATE"
     }
    ]
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": {
    "name": "Topiramate",
    "cas": "97240-79-4",
    "wiki": "https://en.wikipedia.org/wiki/Topiramate",
    "atc": [
     "N03AX11"
    ],
    "names": {
     "inn": [
      "topiramate"
     ],
     "inn_checked": {},
     "languages": {
      "es": [
       "topiramato"
      ],
      "it": [
       "topiramato"
      ],
      "nl": [
       "topiramaat"
      ],
      "pt": [
       "topiramato"
      ],
      "la": [
       "topiramatum"
      ]
     },
     "us_discontinued": [
      "Topamax Sprinkle"
     ],
     "wikidata": [
      "Q221174"
     ],
     "atc_codes": [
      "N03AX11"
     ],
     "snomed": [
      "108400009",
      "386844006"
     ],
     "eu_url": {
      "Qsiva": "https://www.ema.europa.eu/en/medicines/human/EPAR/qsiva"
     },
     "eu_status": {
      "Qsiva": "Refused"
     },
     "it": [
      "TOPAMAX",
      "TOPIRAMATO AUROBINDO",
      "TOPIRAMATO DOC GENERICI",
      "TOPIRAMATO EG",
      "TOPIRAMATO MYLAN GENERICS",
      "TOPIRAMATO SANDOZ",
      "XITOP"
     ],
     "es": [
      "ACOMICIL",
      "TOPAMAX",
      "TOPAMAX DISPERSABLE",
      "TOPIRAMATO AUROVITAS",
      "TOPIRAMATO CINFA",
      "TOPIRAMATO FARMALIDER",
      "TOPIRAMATO KERN PHARMA",
      "TOPIRAMATO NORMON",
      "TOPIRAMATO PENSA PHARMA",
      "TOPIRAMATO PHARMA COMBIX",
      "TOPIRAMATO QUALIGEN",
      "TOPIRAMATO SANDOZ",
      "TOPIRAMATO STADA",
      "TOPIRAMATO TARBIS",
      "TOPIRAMATO TECNIGEN",
      "TOPIRAMATO TEVA-RATIOPHARM",
      "TOPIRAMATO VIATRIS"
     ],
     "ca": [
      "AG-TOPIRAMATE TABLETS",
      "APO-TOPIRAMATE",
      "AURO-TOPIRAMATE",
      "GLN-TOPIRAMATE",
      "JAMP TOPIRAMATE TABLETS",
      "MINT-TOPIRAMATE",
      "MYLAN-TOPIRAMATE",
      "NRA-TOPIRAMATE",
      "PMS-TOPIRAMATE",
      "PRO-TOPIRAMATE",
      "TEVA-TOPIRAMATE",
      "TOPAMAX",
      "TOPIRAMATE"
     ],
     "generic": [],
     "us": [
      "Eprontia",
      "Qsymia",
      "Qudexy",
      "Qudexy Xr",
      "Topamax",
      "Trokendi",
      "Trokendi Xr"
     ],
     "eu": [
      "Qsiva"
     ],
     "fr": [
      "EPITOMAX",
      "TOPIRAMATE ARROW LAB",
      "TOPIRAMATE BGR",
      "TOPIRAMATE SANDOZ",
      "TOPIRAMATE VIATRIS"
     ],
     "rxcui": [
      "38404"
     ],
     "resolved_as": "RxNorm IN",
     "read": "2026-10-03",
     "note": ""
    },
    "atc_list": [
     {
      "code": "N03AX11",
      "route": "systemic",
      "source": "RxNorm"
     }
    ],
    "url": "https://www.dysnet.org/knowledge/teratogens/?q=Topiramate"
   },
   "register_name": "Topiramate"
  },
  "mycophenolate-mofetil": {
   "atc": "L04AA06",
   "epar": [
    {
     "name": "CellCept",
     "number": "EMEA/H/C/000082",
     "status": "Authorised",
     "inn": "mycophenolate mofetil",
     "substance": "mycophenolate mofetil",
     "atc": [
      "L04AA06"
     ],
     "holder": "Roche Registration GmbH",
     "generic": false,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "1996-02-14",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-06-05",
     "therapeutic_area": "Graft Rejection",
     "indication": "CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult and paediatric (1 to 18 years of age) patients receiving allogeneic renal, cardiac or hepatic transplants.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cellcept"
    },
    {
     "name": "Myclausen",
     "number": "EMEA/H/C/001218",
     "status": "Authorised",
     "inn": "mycophenolate mofetil",
     "substance": "mycophenolate mofetil",
     "atc": [
      "L04AA06"
     ],
     "holder": "Passauer Pharma GmbH",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2010-10-07",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-04-10",
     "therapeutic_area": "Graft Rejection",
     "indication": "Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myclausen"
    },
    {
     "name": "Mycophenolate mofetil Teva",
     "number": "EMEA/H/C/000882",
     "status": "Authorised",
     "inn": "mycophenolate mofetil",
     "substance": "mycophenolate mofetil",
     "atc": [
      "L04AA06"
     ],
     "holder": "Teva Pharma B.V.",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2008-02-21",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-04-10",
     "therapeutic_area": "Graft Rejection",
     "indication": "Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mycophenolate-mofetil-teva"
    },
    {
     "name": "Myfenax",
     "number": "EMEA/H/C/000884",
     "status": "Authorised",
     "inn": "mycophenolate mofetil",
     "substance": "mycophenolate mofetil",
     "atc": [
      "L04AA06"
     ],
     "holder": "Teva B.V.",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2008-02-21",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-04-10",
     "therapeutic_area": "Graft Rejection",
     "indication": "Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myfenax"
    }
   ],
   "has_ct": [
    {
     "dossier": "CT-21391",
     "date": "2025-11-19",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3784254",
     "products": [
      "CELLCEPT"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par CELLCEPT 250 mg, 500 mg, 1 g/5 mL (mycophénolate mofétil) est important dans l’extension d’indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "IV",
       "label": "CELLCEPT 250 mg, 500 mg, 1 g/5 mL (mycophénolate mofétil), gélule, comprimé pelliculé, poudre pour suspension buvable, apporte une amélioration mineure (ASMR IV) dans la stratégie thérapeutique actuelle qui comprend les comparateurs pertinents (cf. paragraphe 5.2)."
      }
     ]
    },
    {
     "dossier": "CT-17036",
     "date": "2019-09-04",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3105282",
     "products": [
      "CELLCEPT"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par CELLCEPT reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-13925",
     "date": "2016-06-22",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2656382",
     "products": [
      "MYFORTIC"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités MYFORTIC 180 et 360 mg reste important dans l’indication : « en association avec la ciclosporine et les corticoïdes, pour la prévention du rejet aigu d'organe chez les patients adultes ayant bénéficié d'une allogreffe rénale »."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-432",
     "date": "2004-01-28",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "MYFORTIC"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Cette forme gastro-résistante de mycophénolate sodique (MYFORTIC comprimé) n’apporte pas d’amélioration du service médical par rapport à CELLCEPT comprimé et gélule (forme non gastro-résistante)."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [
     {
      "name": "CellCept",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cellcept",
      "status": "Authorised",
      "kind": "reference"
     },
     {
      "name": "Myclausen",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myclausen",
      "status": "Authorised",
      "kind": "generic"
     },
     {
      "name": "Mycophenolate mofetil Teva",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mycophenolate-mofetil-teva",
      "status": "Authorised",
      "kind": "generic"
     },
     {
      "name": "Myfenax",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myfenax",
      "status": "Authorised",
      "kind": "generic"
     }
    ],
    "FR": [
     {
      "name": "CELLCEPT",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69594306/extrait",
      "products": 4
     },
     {
      "name": "MYCOPHENOLATE MOFETIL ARROW",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64980414/extrait",
      "products": 1
     },
     {
      "name": "MYCOPHENOLATE MOFETIL BIOGARAN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64833033/extrait",
      "products": 2
     },
     {
      "name": "MYCOPHENOLATE MOFETIL SANDOZ",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65743852/extrait",
      "products": 2
     },
     {
      "name": "MYCOPHENOLATE MOFETIL VIATRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66950569/extrait",
      "products": 1
     },
     {
      "name": "MYFENAX",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67572325/extrait",
      "products": 2
     },
     {
      "name": "MYFORTIC",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69678277/extrait",
      "products": 2
     }
    ],
    "ES": [
     {
      "name": "ACIDO MICOFENOLICO STADA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/79535/FT_79535.html",
      "products": 2,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "CELLCEPT",
      "url": "https://cima.aemps.es/cima/dochtml/ft/96005006/FT_96005006.html",
      "products": 10,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "CEPTAVA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/81580/FT_81580.html",
      "products": 2,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO DE MOFETIL STADA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/70658/FT_70658.html",
      "products": 1,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO DE MOFETILO ACCORD",
      "url": "https://cima.aemps.es/cima/dochtml/ft/71521/FT_71521.html",
      "products": 2,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO DE MOFETILO ARISTO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/79323/FT_79323.html",
      "products": 1,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO DE MOFETILO AUROVITAS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/89895/FT_89895.html",
      "products": 1,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO DE MOFETILO CINFA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/80224/FT_80224.html",
      "products": 2,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO DE MOFETILO KERN PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/74562/FT_74562.html",
      "products": 1,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO DE MOFETILO SANDOZ",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69972/FT_69972.html",
      "products": 2,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO DE MOFETILO TECNIGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/76128/FT_76128.html",
      "products": 1,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO MOFETILO ACTAVIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/71151/FT_71151.html",
      "products": 1,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MICOFENOLATO MOFETILO NORMON",
      "url": "https://cima.aemps.es/cima/dochtml/ft/74052/FT_74052.html",
      "products": 2,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MYFENAX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/107438006/FT_107438006.html",
      "products": 3,
      "atc": [
       "L04AA06"
      ]
     },
     {
      "name": "MYFORTIC",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66140/FT_66140.html",
      "products": 2,
      "atc": [
       "L04AA06"
      ]
     }
    ],
    "UK": [],
    "IT": [
     {
      "name": "ACIDO MICOFENOLICO ACCORD"
     },
     {
      "name": "ACIDO MICOFENOLICO TILLOMED"
     },
     {
      "name": "CELLCEPT"
     },
     {
      "name": "CEPTAVA"
     },
     {
      "name": "MICOFENOLATO MOFETILE ACCORD"
     },
     {
      "name": "MICOFENOLATO MOFETILE AHCL"
     },
     {
      "name": "MICOFENOLATO MOFETILE AUROBINDO"
     },
     {
      "name": "MICOFENOLATO MOFETILE SANDOZ"
     },
     {
      "name": "MICOFENOLATO MOFETILE TILLOMED"
     },
     {
      "name": "MICOFENOLATO MOFETILE TILLOMED ITALIA"
     },
     {
      "name": "MYCOPHENOLATE MOFETIL TEVA"
     },
     {
      "name": "MYFENAX"
     },
     {
      "name": "MYFORTIC"
     }
    ],
    "US": [
     {
      "name": "Cellcept"
     },
     {
      "name": "Myfortic"
     },
     {
      "name": "Myhibbin"
     }
    ],
    "US_discontinued": [],
    "CA": [
     {
      "name": "ACH-MYCOPHENOLATE"
     },
     {
      "name": "APO-MYCOPHENOLIC ACID"
     },
     {
      "name": "CELLCEPT"
     },
     {
      "name": "CELLCEPT I.V."
     },
     {
      "name": "JAMP MYCOPHENOLIC ACID"
     },
     {
      "name": "JAMP-MYCOPHENOLATE"
     },
     {
      "name": "JAMP-MYCOPHENOLATE CAPSULES"
     },
     {
      "name": "MAR-MYCOPHENOLATE MOFETIL"
     },
     {
      "name": "MAR-MYCOPHENOLIC ACID"
     },
     {
      "name": "MYCOPHENOLATE MOFETIL"
     },
     {
      "name": "MYCOPHENOLATE MOFETIL FOR INJECTION"
     },
     {
      "name": "MYFORTIC"
     },
     {
      "name": "SANDOZ MYCOPHENOLATE MOFETIL"
     },
     {
      "name": "TEVA-MYCOPHENOLATE"
     }
    ]
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": {
    "name": "Mycophenolate mofetil and mycophenolic acid",
    "cas": "128794-94-5",
    "wiki": null,
    "names": {
     "inn": [
      "mycophenolic acid"
     ],
     "inn_checked": {},
     "languages": {
      "fr": [
       "acide mycophenolique",
       "mycophénolate mofétil"
      ],
      "de": [
       "Mycophenolat-Mofetil",
       "Mycophenolsäure"
      ],
      "es": [
       "acido micofenolico"
      ],
      "it": [
       "acido micofenolico",
       "Micofenolato mofetile"
      ],
      "nl": [
       "mycofenolzuur"
      ],
      "pt": [
       "mofetil micofenolato",
       "Ácido micofenólico"
      ],
      "la": [
       "acidum mycophenolicum"
      ]
     },
     "us_discontinued": [],
     "wikidata": [
      "Q420553",
      "Q4567614"
     ],
     "atc_codes": [
      "L04AA06"
     ],
     "snomed": [
      "386976000",
      "409330005",
      "409331009",
      "441632007"
     ],
     "eu_url": {
      "CellCept": "https://www.ema.europa.eu/en/medicines/human/EPAR/cellcept",
      "Mycophenolate mofetil Teva": "https://www.ema.europa.eu/en/medicines/human/EPAR/mycophenolate-mofetil-teva",
      "Myfenax": "https://www.ema.europa.eu/en/medicines/human/EPAR/myfenax",
      "Myclausen": "https://www.ema.europa.eu/en/medicines/human/EPAR/myclausen"
     },
     "eu_status": {
      "CellCept": "Authorised",
      "Mycophenolate mofetil Teva": "Authorised",
      "Myfenax": "Authorised",
      "Myclausen": "Authorised"
     },
     "it": [
      "ACIDO MICOFENOLICO ACCORD",
      "ACIDO MICOFENOLICO TILLOMED",
      "CELLCEPT",
      "CEPTAVA",
      "MICOFENOLATO MOFETILE ACCORD",
      "MICOFENOLATO MOFETILE AHCL",
      "MICOFENOLATO MOFETILE AUROBINDO",
      "MICOFENOLATO MOFETILE SANDOZ",
      "MICOFENOLATO MOFETILE TILLOMED",
      "MICOFENOLATO MOFETILE TILLOMED ITALIA",
      "MYCOPHENOLATE MOFETIL TEVA",
      "MYFENAX",
      "MYFORTIC"
     ],
     "es": [
      "ACIDO MICOFENOLICO STADA",
      "CELLCEPT",
      "CEPTAVA",
      "MICOFENOLATO DE MOFETILO ACCORD",
      "MICOFENOLATO DE MOFETILO ARISTO",
      "MICOFENOLATO DE MOFETILO AUROVITAS",
      "MICOFENOLATO DE MOFETILO CINFA",
      "MICOFENOLATO DE MOFETILO KERN PHARMA",
      "MICOFENOLATO DE MOFETILO SANDOZ",
      "MICOFENOLATO DE MOFETILO STADA",
      "MICOFENOLATO DE MOFETILO TECNIGEN",
      "MICOFENOLATO DE MOFETILO TILLOMED",
      "MICOFENOLATO MOFETILO NORMON",
      "MICOFENOLATO MOFETILO TEVA",
      "MYFENAX",
      "MYFORTIC"
     ],
     "ca": [
      "ACH-MYCOPHENOLATE",
      "APO-MYCOPHENOLIC ACID",
      "CELLCEPT",
      "CELLCEPT I.V.",
      "JAMP MYCOPHENOLIC ACID",
      "JAMP-MYCOPHENOLATE",
      "JAMP-MYCOPHENOLATE CAPSULES",
      "MAR-MYCOPHENOLATE MOFETIL",
      "MAR-MYCOPHENOLIC ACID",
      "MYCOPHENOLATE MOFETIL",
      "MYCOPHENOLATE MOFETIL FOR INJECTION",
      "MYFORTIC",
      "SANDOZ MYCOPHENOLATE MOFETIL",
      "TEVA-MYCOPHENOLATE"
     ],
     "generic": [
      "mycophenolate mofetil hydrochloride"
     ],
     "us": [
      "Cellcept",
      "Myfortic",
      "Myhibbin"
     ],
     "eu": [
      "CellCept",
      "Myclausen",
      "Mycophenolate mofetil Teva",
      "Myfenax"
     ],
     "fr": [
      "CELLCEPT",
      "MYCOPHENOLATE MOFETIL ARROW",
      "MYCOPHENOLATE MOFETIL BIOGARAN",
      "MYCOPHENOLATE MOFETIL SANDOZ",
      "MYCOPHENOLATE MOFETIL TEVA",
      "MYCOPHENOLATE MOFETIL VIATRIS",
      "MYFENAX",
      "MYFORTIC"
     ],
     "rxcui": [
      "68149",
      "7145"
     ],
     "resolved_as": "RxNorm mycophenolate mofetil + mycophenolic acid",
     "read": "2026-10-03",
     "note": ""
    },
    "atc_list": [
     {
      "code": "L04AA06",
      "route": "systemic",
      "source": "RxNorm"
     }
    ],
    "url": "https://www.dysnet.org/knowledge/teratogens/?q=Mycophenolate%20mofetil%20and%20mycophenolic%20acid"
   },
   "register_name": "Mycophenolate mofetil and mycophenolic acid"
  },
  "adalimumab": {
   "atc": "L04AB04",
   "epar": [
    {
     "name": "Amgevita",
     "number": "EMEA/H/C/004212",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Amgen Europe B.V.",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2017-03-21",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-08-18",
     "therapeutic_area": "Arthritis, Psoriatic;Colitis, Ulcerative;Arthritis, Juvenile Rheumatoid;Spondylitis, Ankylosing;Psoriasis;Crohn Disease;Arthritis, Rheumatoid",
     "indication": "Rheumatoid arthritis Amgevita in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Amgevita reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amgevita in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Amgevita is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs. Psoriatic arthritis Amgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Amgevita reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function. Psoriasis Amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Amgevita is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Amgevita is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Amgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Amgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Amgevita is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita"
    },
    {
     "name": "Amsparity",
     "number": "EMEA/H/C/004879",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Pfizer Europe MA EEIG",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2020-02-13",
     "refused": null,
     "withdrawn": null,
     "updated": "2025-10-22",
     "therapeutic_area": "Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Crohn Disease;Arthritis, Juvenile Rheumatoid",
     "indication": "Rheumatoid arthritis Amsparity in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amsparity in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Amsparity is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis Ankylosing spondylitis (AS) Amsparity is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Amsparity is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Amsparity is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Amsparity is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amsparity is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Amsparity is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Amsparity is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Amsparity is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Amsparity is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Adolescent hidradenitis suppurativa Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Paediatric uveitis Amsparity is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amsparity"
    },
    {
     "name": "Hefiya",
     "number": "EMEA/H/C/004865",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Sandoz GmbH",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2018-07-26",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-02-16",
     "therapeutic_area": "Spondylitis, Ankylosing;Hidradenitis Suppurativa;Psoriasis;Arthritis, Juvenile Rheumatoid;Uveitis",
     "indication": "Rheumatoid arthritis Hefiya in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hefiya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Hefiya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Hefiya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Hefiya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Hefiya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Hefiya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hefiya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Paediatric plaque psoriasis Hefiya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Hefiya is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Hefiya is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hefiya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric ulcerative colitis Hefiya is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Ulcerative colitis Hefiya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Hefiya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hefiya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya"
    },
    {
     "name": "Hukyndra",
     "number": "EMEA/H/C/005548",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Stada Arzneimittel AG",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2021-11-15",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-07-17",
     "therapeutic_area": "Arthritis, Psoriatic;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid;Colitis, Ulcerative;Crohn Disease;Hidradenitis Suppurativa;Psoriasis;Spondylitis, Ankylosing;Uveitis",
     "indication": "Rheumatoid arthritis Hukyndra in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hukyndra in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more DMARD. Hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Hukyndra is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Hukyndra is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Hukyndra is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Hukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Hukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hukyndra is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Hukyndra is indicated for the treatment of active moderate to severe HS (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Hukyndra is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hukyndra is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Hukyndra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Hukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Hukyndra is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hukyndra is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra"
    },
    {
     "name": "Hulio",
     "number": "EMEA/H/C/004429",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Biosimilar Collaborations Ireland Limited",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2018-09-17",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-08-27",
     "therapeutic_area": "Hidradenitis Suppurativa;Psoriasis;Uveitis;Arthritis, Rheumatoid;Spondylitis, Ankylosing;Crohn Disease;Colitis, Ulcerative;Arthritis, Psoriatic",
     "indication": "Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hulio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Hulio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Paediatric plaque psoriasis Hulio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Paediatric Crohn's disease Hulio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric Uveitis Hulio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hulio"
    },
    {
     "name": "Humira",
     "number": "EMEA/H/C/000481",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "AbbVie Deutschland GmbH & Co. KG",
     "generic": false,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2003-09-08",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-08-05",
     "therapeutic_area": "Spondylitis, Ankylosing;Arthritis, Juvenile Rheumatoid;Uveitis;Colitis, Ulcerative;Psoriasis;Arthritis, Psoriatic;Crohn Disease;Arthritis, Rheumatoid",
     "indication": "Please refer to the product information document.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/humira"
    },
    {
     "name": "Hyrimoz",
     "number": "EMEA/H/C/004320",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Sandoz GmbH",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2018-07-26",
     "refused": null,
     "withdrawn": null,
     "updated": "2025-12-11",
     "therapeutic_area": "Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Arthritis, Juvenile Rheumatoid;Crohn Disease;Skin Diseases, Papulosquamous",
     "indication": "Rheumatoid arthritis Hyrimoz in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis - Polyarticular juvenile idiopathic arthritis Hyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Adalimumab has not been studied in patients aged less than 2 years. - Enthesitis-related arthritis Hyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis - Ankylosing spondylitis (AS) Hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. - Axial spondyloarthritis without radiographic evidence of AS Hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Hyrimoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hyrimoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric ulcerative colitis Hyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Ulcerative colitis Hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz"
    },
    {
     "name": "Idacio",
     "number": "EMEA/H/C/004475",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Fresenius Kabi Deutschland GmbH",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2019-04-02",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-08-06",
     "therapeutic_area": "Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Crohn Disease;Arthritis, Juvenile Rheumatoid",
     "indication": "Rheumatoid arthritis Idacio in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Idacio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Idacio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Idacio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Idacio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Idacio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Idacio is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Idacio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Idacio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Idacio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric Uveitis Idacio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/idacio"
    },
    {
     "name": "Imraldi",
     "number": "EMEA/H/C/004279",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Samsung Bioepis NL B.V.",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2017-08-24",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-02-04",
     "therapeutic_area": "Spondylitis, Ankylosing;Arthritis, Rheumatoid;Uveitis;Colitis, Ulcerative;Psoriasis;Arthritis, Psoriatic;Crohn Disease;Hidradenitis Suppurativa;Arthritis",
     "indication": "Rheumatoid arthritis Imraldi in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Imraldi in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Imraldi is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Imraldi is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Imraldi is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Imraldi is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function. Psoriasis Imraldi is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Imraldi is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Imraldi is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Imraldi is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have Ulcerative colitis Imraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Imraldi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Imraldi is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. Paediatric Uveitis Imraldi is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi"
    },
    {
     "name": "Libmyris",
     "number": "EMEA/H/C/005947",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Stada Arzneimittel AG",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2021-11-12",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-07-13",
     "therapeutic_area": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Psoriasis;Hidradenitis Suppurativa;Crohn Disease;Colitis, Ulcerative;Uveitis",
     "indication": "Rheumatoid arthritis Libmyris in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Libmyris in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more DMARD. Libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Libmyris is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis Ankylosing spondylitis (AS) Libmyris is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Libmyris is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Libmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Libmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Libmyris is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Libmyris is indicated for the treatment of active moderate to severe HS (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Libmyris is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Libmyris is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Libmyris is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Libmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Libmyris is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Libmyris is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris"
    },
    {
     "name": "Yuflyma",
     "number": "EMEA/H/C/005188",
     "status": "Authorised",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Celltrion Healthcare Hungary Kft.",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2021-02-11",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-09-25",
     "therapeutic_area": "Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Crohn Disease;Arthritis, Juvenile Rheumatoid",
     "indication": "Rheumatoid arthritis Yuflyma in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Yuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Yuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Yuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis Yuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Yuflyma is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Yuflyma is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Yuflyma is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Yuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Yuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Yuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma"
    },
    {
     "name": "Cyltezo",
     "number": "EMEA/H/C/004319",
     "status": "Withdrawn",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Boehringer Ingelheim International GmbH",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": true,
     "conditional": false,
     "authorised": "2017-11-10",
     "refused": null,
     "withdrawn": "2019-01-15",
     "updated": "2019-03-06",
     "therapeutic_area": "Hidradenitis Suppurativa;Arthritis, Psoriatic;Psoriasis;Crohn Disease;Arthritis, Juvenile Rheumatoid;Uveitis;Arthritis, Rheumatoid;Colitis, Ulcerative;Spondylitis, Ankylosing",
     "indication": "Please refer to section 4.1 of the Summary of product characteristics in the product information document.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo"
    },
    {
     "name": "Fyzoclad",
     "number": "EMEA/H/C/005253",
     "status": "Application withdrawn",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Pfizer Europe MA EEIG",
     "generic": false,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": null,
     "refused": null,
     "withdrawn": null,
     "updated": null,
     "therapeutic_area": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Psoriasis;Arthritis, Psoriatic;Spondylitis, Ankylosing;Uveitis",
     "indication": "Treatment of juvenile idiopathic arthritis, paediatric plaque psoriasis, paediatric uveitis",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fyzoclad"
    },
    {
     "name": "Halimatoz",
     "number": "EMEA/H/C/004866",
     "status": "Withdrawn",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Sandoz GmbH",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": true,
     "conditional": false,
     "authorised": "2018-07-26",
     "refused": null,
     "withdrawn": "2020-12-18",
     "updated": "2021-01-29",
     "therapeutic_area": "Hidradenitis Suppurativa;Psoriasis;Arthritis, Juvenile Rheumatoid;Uveitis;Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic",
     "indication": "Rheumatoid arthritis Halimatoz in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Halimatoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Halimatoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Axial spondyloarthritis Ankylosing spondylitis (AS) Halimatoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Halimatoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Halimatoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Halimatoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Halimatoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Halimatoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Halimatoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Halimatoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis/ Uveitis/ Paediatric uveitis For full indication see 4.1.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz"
    },
    {
     "name": "Kromeya",
     "number": "EMEA/H/C/005158",
     "status": "Withdrawn",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Fresenius Kabi Deutschland GmbH",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": true,
     "conditional": false,
     "authorised": "2019-04-02",
     "refused": null,
     "withdrawn": null,
     "updated": "2020-03-25",
     "therapeutic_area": "Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Psoriasis;Arthritis, Psoriatic;Spondylitis, Ankylosing;Uveitis;Colitis, Ulcerative;Crohn Disease",
     "indication": "Rheumatoid arthritis Kromeya in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Kromeya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Kromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Kromeya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Kromeya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Kromeya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Kromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Kromeya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Crohn’s disease Kromeya is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Kromeya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Kromeya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Kromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. Paediatric Uveitis Kromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya"
    },
    {
     "name": "Solymbic",
     "number": "EMEA/H/C/004373",
     "status": "Withdrawn",
     "inn": "adalimumab",
     "substance": "adalimumab",
     "atc": [
      "L04AB04"
     ],
     "holder": "Amgen Europe B.V.",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": true,
     "conditional": false,
     "authorised": "2017-03-22",
     "refused": null,
     "withdrawn": "2018-06-15",
     "updated": "2019-03-05",
     "therapeutic_area": "Arthritis, Psoriatic;Spondylitis, Ankylosing;Crohn Disease;Colitis, Ulcerative;Hidradenitis Suppurativa;Psoriasis;Arthritis, Rheumatoid",
     "indication": "Please refer to section 4.1 of the Summary of product characteristics in the product information document.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic"
    }
   ],
   "has_ct": [
    {
     "dossier": "CT-19533",
     "date": "2023-03-15",
     "motif": "Réévaluation SMR et ASMR",
     "url": "https://www.has-sante.fr/jcms/p_3426145",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par HUMIRA (adalimumab) devient important dans l’indication de son AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-18801",
     "date": "2022-12-14",
     "motif": "Réévaluation suite à résultats étude post-inscript",
     "url": "https://www.has-sante.fr/jcms/p_3402381",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par HUMIRA (adalimumab) reste important dans le traitement de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués."
      }
     ],
     "asmr": [
      {
       "value": "Commentaires sans chiffrage de l'ASMR",
       "label": "La Commission estime que les nouvelles données ne sont pas de nature à modifier l’appréciation de l’amélioration du service médical rendu formulée dans l’avis précédent du 24 juillet 2013."
      }
     ]
    },
    {
     "dossier": "CT-18987",
     "date": "2021-05-19",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3273456",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par HUMIRA (adalimumab) est important dans cette extension d’indication de l’AMM dans le traitement de la RCH chez l’enfant à partir de 6 ans et l’adolescent."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Compte tenu :\n• de la faible qualité de la démonstration de l’efficacité clinique de l’adalimumab (HUMIRA) dans cette indication basée sur les résultats d’une étude non comparative (après amendement au protocole) et sur une comparaison à un placebo externe dont les résultats ne sont pas interprétables,\n• de l’absence de donnée comparative versus infliximab (REMICADE et ses biosimilaires), autre anti-TNF disposant d’une AMM, alors que cette comparaison était possible,\nmais prenant en compte :\n• l’intérêt potentiel de disposer d’une forme sous-cutanée chez l’enfant et,\n• le profil d’efficacité et de tolérance établi de l’adalimumab chez l’adulte et dans d’autres indications pédiatriques notamment la maladie de Crohn,\nla Commission de la Transparence considère qu’HUMIRA (adalimumab) n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie de prise en charge de la RCH active modérée à sévère chez les enfants et les adolescents à partir de 6 ans ayant eu une réponse inadéquate au traitement conventionnel, comprenant les corticoïdes et/ou l’azathioprine (AZA) ou la 6-mercaptopurine (6-MP), ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués."
      }
     ]
    },
    {
     "dossier": "CT-19118",
     "date": "2021-05-05",
     "motif": "Réévaluation suite à résultats étude post-inscript",
     "url": "https://www.has-sante.fr/jcms/p_3270042",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités HUMIRA 40 et 80 mg (adalimumab), solution injectable en seringue préremplie et en stylo prérempli devient important dans l’indication de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-18876",
     "date": "2021-03-03",
     "motif": "Réévaluation SMR et ASMR",
     "url": "https://www.has-sante.fr/jcms/p_3244158",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Faible",
       "label": "Le service médical rendu par HUMIRA (adalimumab) 40 mg/0,4 ml et 80 mg/0,8 ml, solution injectable en seringue préremplie et en stylo prérempli est faible dans l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Compte tenu :\n• de la démonstration d’une supériorité de l’adalimumab versus placebo dans une nouvelle étude de phase IV, sur un critère de jugement déjà jugé comme peu pertinent, à savoir la réduction du nombre de lésions inflammatoires évalué par le score Hi-SCR après 12 semaines de traitement, chez des adultes ayant une hidrosadénite suppurée active modérée à sévère candidats à la chirurgie, et avec une quantité d’effet modeste .\n• de l’absence de démonstration d’un impact sur le recours à la chirurgie programmée (annulation ou réduction de son étendue), critère plus cliniquement pertinent,\n• d’un profil de tolérance à moyen terme marqué par la survenue d’infections graves et opportunistes, de tumeurs malignes dans cette pathologie au risque infectieux et oncogène non négligeable .\n• de l’absence de bénéfice démontré en termes de qualité de vie, pourtant particulièrement altérée dans les formes sévères de cette maladie,\n• et malgré le besoin médical identifié en cas de réponse insuffisante de l’antibioprophylaxie,\nla Commission de la Transparence considère que HUMIRA (adalimumab), n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie de prise en charge de l’hidrosadénite suppurée."
      }
     ]
    },
    {
     "dossier": "CT-17996",
     "date": "2019-12-04",
     "motif": "Modification des conditions d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3145045",
     "products": [
      "IMRALDI"
     ],
     "smr": [
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par IMRALDI est identique à celui d’HUMIRA dans cette extension d’indication, à savoir insuffisant pour justifier d’une prise en charge par la solidarité nationale dans les autres cas d’uvéite antérieure chronique non infectieuse."
      },
      {
       "value": "Modéré",
       "label": "Le service médical rendu par IMRALDI est identique à celui d’HUMIRA dans cette extension d’indication, à savoir modéré, en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "En tant que médicament biosimilaire, IMRALDI n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la biothérapie de référence, HUMIRA, en association au méthotrexate dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié."
      }
     ]
    },
    {
     "dossier": "CT-17904",
     "date": "2019-11-20",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3143614",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par HUMIRA 80 mg, solution injectable en stylo prérempli (B/3) est important dans le traitement :\n• de la polyarthrite rhumatoïde modérément à sévèrement active de l'adulte lorsque la réponse aux traitements de fond, y compris le méthotrexate est inadéquate. Humira peut être donné en monothérapie en cas d’intolérance au méthotrexate ou lorsque la poursuite du traitement avec le méthotrexate est inadaptée .\n• du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, défini par :\no un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie\no et une forme étendue et/ou un retentissement psychosocial important .\n• de la maladie de Crohn active, modérée à sévère chez l'adulte .\n• de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués .\n• de la rectocolite hémorragique de l’adulte .\n• de l’uvéite de l’adulte."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par HUMIRA 80 mg, solution injectable en stylo prérempli (B/3) est insuffisant pour justifier d’une prise en charge par la solidarité nationale dans :\n• le traitement de la polyarthrite rhumatoïde sévère, en association au méthotrexate, active et évolutive chez les adultes non précédemment traités par le méthotrexate .\n• le traitement du psoriasis en plaques de l’adulte, pour les autres patients ne répondant pas à ces critères de mise sous traitement .\n• le traitement de l’hidrosadénite suppurée.\n• les autres cas d’uvéites antérieures chroniques non infectieuses de l’enfant à partir de 2 ans et de l’adolescent."
      },
      {
       "value": "Modéré",
       "label": "Le service médical rendu par HUMIRA 80 mg, solution injectable en stylo prérempli (B/3) est modéré, en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette présentation est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-17766",
     "date": "2019-06-26",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3080455",
     "products": [
      "IDACIO"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les présentations IDACIO est important dans l’indication de l’AMM dans le traitement :\n• de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans) . et uniquement pour les présentations en seringue et stylos préremplis dans le traitement :\n• de la spondylarthrite ankylosante,\n• du rhumatisme psoriasique,\n• de la maladie de Crohn active chez l'adulte\n• de la rectocolite hémorragique de l’adulte,\n• de l’uvéite de l’adulte.\n\nAussi, le service médical rendu par les présentations IDACIO est important dans un périmètre restreint dans le traitement :\n• de la polyarthrite rhumatoïde en cas de réponse inadéquate aux traitements de fond, y compris le méthotrexate (uniquement présentations en seringue et stylos préremplis).\n• du psoriasis en plaques de l’enfant à partir de 4 ans et adolescent (pour l’adulte les uniquement présentations en seringue et stylos préremplis), chez les patients ayant un psoriasis en plaques chronique sévère, défini par :\no un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie,\no et une forme étendue et/ou un retentissement psychosocial important,\n• de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par IDACIO, présentations en seringue et stylos préremplis, est insuffisant dans le traitement : de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate . du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement . de l’hidrosadénite suppurée de l’adulte . des autres cas d’uvéite antérieure chronique non infectieuse de l’enfant et l’adolescent.\n\nLe service médical rendu par IDACIO, présentation en flacon, est insuffisant dans le traitement : du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement . des autres cas d’uvéite antérieure chronique non infectieuse de l’enfant et l’adolescent."
      },
      {
       "value": "Modéré",
       "label": "Le service médical rendu par les spécialités IDACIO est modéré dans un périmètre restreint en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié."
      },
      {
       "value": "Non précisé",
       "label": "Le service médical rendu par les spécialités IDACIO n’a pas été évalué dans le traitement de l'hidrosadénite suppurée chez les adolescents à partir de 12 ans car l’inscription dans cette indication n’a pas été sollicitée pour la spécialité de référence HUMIRA."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "En tant que médicament biosimilaire, les spécialités IDACIO n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport à la spécialité de référence HUMIRA."
      }
     ]
    },
    {
     "dossier": "CT-17555",
     "date": "2019-02-06",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2905742",
     "products": [
      "IMRALDI"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu est important dans l’indication de l’AMM dans le traitement :\n• de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans),\n• de la spondylarthrite ankylosante,\n• du rhumatisme psoriasique,\n• de la maladie de Crohn active chez l'adulte\n• de la rectocolite hémorragique de l’adulte,\n• de l’uvéite de l’adulte.\n\nLe service médical rendu est important dans un périmètre restreint dans le traitement :\n• de la polyarthrite rhumatoïde en cas de réponse inadéquate aux traitements de fond, y compris le méthotrexate,\n• du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, défini par :\no un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie,\no et une forme étendue et/ou un retentissement psychosocial important,\n• du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère, défini par :\no un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie,\no et une forme étendue et/ou un retentissement psychosocial important,\n• de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués,"
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu est insuffisant dans le traitement :\n• de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate,\n• du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement,\n• de l’hidrosadénite suppurée."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-17415",
     "date": "2018-11-21",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2886950",
     "products": [
      "HULIO"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par cette spécialité est important dans un périmètre restreint dans le traitement :\n• de la polyarthrite rhumatoïde en cas de réponse inadéquate aux traitements de fond, y compris le méthotrexate,\n• du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie, et une forme étendue et/ou un retentissement psychosocial important,\n• du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie, et une forme étendue et/ou un retentissement psychosocial important,\n• de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués,"
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par cette spécialité est insuffisant dans le traitement :\n• de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate,\n• du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement,\n• de l’hidrosadénite suppurée de l’adulte,\n• des autres cas d’uvéite antérieure chronique non infectieuse de l’enfant et l’adolescent."
      },
      {
       "value": "Modéré",
       "label": "Le service médical rendu par cette spécialité est modéré dans un périmètre restreint :\n• en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié."
      },
      {
       "value": "Important",
       "label": "Le service médical rendu par cette spécialité est important dans l’indication de l’AMM dans le traitement :\n• de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans),\nLe service médical rendu est important dans un périmètre restreint dans le traitement :\n• du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère, défini par : un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie, et une forme étendue et/ou un retentissement psychosocial important,\n• de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués,"
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par cette spécialité est insuffisant dans le traitement :\n• du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement,\n• des autres cas d’uvéite antérieure chronique non infectieuse de l’enfant et l’adolescent."
      },
      {
       "value": "Modéré",
       "label": "Le service médical rendu par cette spécialité est modéré dans un périmètre restreint :\n• en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié"
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "En tant que médicament biosimilaire, HULIO n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la biothérapie de référence, HUMIRA."
      }
     ]
    },
    {
     "dossier": "CT-17068",
     "date": "2018-07-11",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2867463",
     "products": [
      "IMRALDI"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu est important dans le traitement :\n\n• de la polyarthrite rhumatoïde modérément à sévèrement active de l'adulte lorsque la réponse aux traitements de fond, y compris le méthotrexate est inadéquate, en association au méthotrexate. IMRALDI peut être donné en monothérapie en cas d'intolérance au méthotrexate ou lorsque la poursuite du traitement avec le méthotrexate est inadaptée.\n• de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans) .\n• de la spondylarthrite ankylosante sévère et active chez l’adulte ayant eu une réponse inadéquate au traitement conventionnel et de la spondyloarthrite axiale sévère sans signes radiographiques de SA,\n• du rhumatisme psoriasique actif et évolutif chez les adultes lorsque la réponse à un traitement de fond antérieur a été inadéquate,\n• du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère,\n• du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère,\n• de la maladie de Crohn active, modérée à sévère chez l'adulte .\n• de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués.\n• de la rectocolite hémorragique de l’adulte,\n• de l’uvéite de l’adulte."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu est insuffisant dans le traitement :\n• de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate,\n• du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement,\n• de l’hidrosadénite suppurée"
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "En tant que médicament biosimilaire, IMRALDI n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la biothérapie de référence, HUMIRA."
      }
     ]
    },
    {
     "dossier": "CT-16979",
     "date": "2018-07-11",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2865430",
     "products": [
      "AMGEVITA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu est important dans le traitement :\n\n• de la polyarthrite rhumatoïde modérément à sévèrement active de l'adulte lorsque la réponse aux traitements de fond, y compris le méthotrexate est inadéquate, en association au méthotrexate. AMGEVITA peut être donné en monothérapie en cas d'intolérance au méthotrexate ou lorsque la poursuite du traitement avec le méthotrexate est inadaptée,\n• de l’arthrite juvénile idiopathique (arthrite juvénile idiopathique polyarticulaire à partir de 2 ans et arthrite liée à l’enthésite à partir de 6 ans),\n• de la spondylarthrite ankylosante sévère et active chez l’adulte ayant eu une réponse inadéquate au traitement conventionnel et de la spondyloarthrite axiale sévère sans signes radiographiques de SA,\n• du rhumatisme psoriasique actif et évolutif chez les adultes lorsque la réponse à un traitement de fond antérieur a été inadéquate,\n• du psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère,\n• du psoriasis en plaques de l’enfant à partir de 4 ans et de l’adolescent, chez les patients ayant un psoriasis en plaques chronique sévère,\n• de la maladie de Crohn active, modérée à sévère chez l'adulte,\n• de la maladie de Crohn active, sévère, chez les enfants et les adolescents à partir de de 6 ans, qui n'ont pas répondu à un traitement conventionnel comprenant un corticoïde, un immunomodulateur et un traitement nutritionnel de première intention . ou chez lesquels ces traitements sont mal tolérés ou contre-indiqués,\n• de la rectocolite hémorragique de l’adulte,\n• de l’uvéite de l’adulte."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu est insuffisant dans le traitement :\n• de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate (en association au méthotrexate),\n• du psoriasis en plaques pour les autres patients ne répondant pas à ces critères de mise sous traitement,\n• de l’hidrosadénite suppurée"
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "En tant que médicament biosimilaire, AMGEVITA n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la biothérapie de référence, HUMIRA."
      }
     ]
    },
    {
     "dossier": "CT-16061",
     "date": "2018-07-11",
     "motif": "Extension d'indication non sollicitée",
     "url": "https://www.has-sante.fr/jcms/c_2865442",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Non précisé",
       "label": "Le laboratoire ne demande pas l’inscription dans « le traitement de l’hidrosadéniste suppurée (maladie de Verneuil) active, modérée à sévère, chez les adolescents à partir de 12 ans en cas de réponse insuffisante au traitement systémique conventionnel de l’HS ». De ce fait ces spécialités ne sont pas remboursables ni agréées aux collectivités dans cette indication.\n."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-16820",
     "date": "2018-06-13",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_2862987",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par HUMIRA est insuffisant pour justifier d’une prise en charge par la solidarité nationale dans les autres cas d’uvéite antérieure chronique non infectieuse."
      },
      {
       "value": "Modéré",
       "label": "Le service médical rendu par HUMIRA est modéré, en association au méthotrexate, dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié ."
      }
     ],
     "asmr": [
      {
       "value": "IV",
       "label": "Compte tenu de :\n• la démonstration de la supériorité d’adalimumab en association au méthotrexate, par rapport au placebo sur le délai la survenue d’une nouvelle poussée inflammatoire (étude SYCAMORE), critère de jugement pertinent dans cette maladie,\n• des critères d’inclusion des études restreignant la population aux patients ayant une arthrite juvénile idiopathique associée à leur uvéite,\n• des incertitudes sur la réelle quantité d’effet du fait de nombreux biais méthodologiques (nombre important de violations majeures au protocole et arrêt prématuré de l’étude SYCAMORE),\n• de l’absence de démonstration d’un impact sur la qualité de vie,\n• et des incertitudes sur l’efficacité et la tolérance à long terme,\nla Commission considère qu’HUMIRA en association au méthotrexate apporte une amélioration du service médical rendu mineure (ASMR IV) dans le traitement de l’uvéite antérieure chronique non infectieuse associée à une arthrite juvénile idiopathique chez l’enfant à partir de 2 ans et l’adolescent, en cas de réponse insuffisante ou d’intolérance au traitement conventionnel ou pour lesquels un traitement conventionnel est inapproprié."
      }
     ]
    },
    {
     "dossier": "CT-15576",
     "date": "2017-01-25",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_2745260",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par HUMIRA est important dans l’extension d'indication : traitement de l’uvéite non infectieuse, intermédiaire, postérieure et de la panuvéite chez les patients adultes ayant eu une réponse insuffisante à la corticothérapie, chez les patients nécessitant une épargne cortisonique, ou chez lesquels la corticothérapie est inappropriée."
      }
     ],
     "asmr": [
      {
       "value": "IV",
       "label": "Compte tenu :\n• de la démonstration de la supériorité de l’adalimumab par rapport au placebo sur le pourcentage de patients ayant eu une rechute à partir de la 6ème semaine de traitement chez des patients atteints d’uvéite non infectieuse intermédiaire, postérieure ou de panuvéite non infectieuse en échec à la corticothérapie ou corticodépendante,\n• de la confirmation de cette efficacité en pratique réelle en termes de réponse complète et de rechute,\n• mais de la quantité d’effet modérée,\n• des données de tolérance,\n• de l’absence de comparateur cliniquement pertinent,\n• de l’absence de données d’efficacité et de tolérance à long terme et de démonstration d’un impact sur la qualité de vie,\nla Commission considère que HUMIRA apporte une amélioration du service médical rendu mineure (ASMR IV) dans le traitement de l’uvéite non infectieuse, intermédiaire, postérieure et de la panuvéite non infectieuse chez les patients adultes ayant eu une réponse insuffisante à la corticothérapie, chez les patients nécessitant une épargne cortisonique, ou chez lesquels la corticothérapie est inappropriée."
      }
     ]
    },
    {
     "dossier": "CT-15008",
     "date": "2016-06-22",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2625986",
     "products": [
      "HUMIRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par HUMIRA 40 mg/0,4 mL, solution injectable en seringue préremplie et en stylo prérempli est important dans le traitement de :\n• la polyarthrite rhumatoïde modérément à sévèrement active de l'adulte lorsque la réponse aux traitements de fond, y compris le méthotrexate, est inadéquate.\n• l’arthrite juvénile idiopathique\no arthrite juvénile idiopathique polyarticulaire\no arthrite liée à l’enthésite\n• la spondyloarthrite axiale chez l’adulte\no spondylarthrite ankylosante (SA)\no spondyloarthrite axiale sans signes radiographiques de SA\n• le rhumatisme psoriasique chez l’adulte\n• la maladie de Crohn chez l’adulte\n• la maladie de Crohn chez l'enfant et l’adolescent\n• la rectocolite hémorragique chez l’adulte\n• le psoriasis en plaques de l’adulte, chez les patients ayant un psoriasis en plaques chronique sévère, défini par :\no un échec (réponse insuffisante, contre-indication ou intolérance) à au moins deux traitements parmi les traitements systémiques non biologiques et la photothérapie\no et une forme étendue et/ou un retentissement psychosocial important.\nDans le traitement de la polyarthrite rhumatoïde sévère, active et évolutive chez les adultes non précédemment traités par le méthotrexate, le service médical rendu reste important dans l’attente de sa réévaluation par la Commission de la transparence."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par HUMIRA 40 mg/0,4 mL, solution injectable en seringue préremplie et en stylo prérempli est insuffisant dans le traitement :\n• du psoriasis en plaques de l’adulte, pour les autres patients ne répondant pas à ces critères de mise sous traitement\n• de l’hidrosadénite suppurée."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [
     {
      "name": "Amgevita",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Amsparity",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/amsparity",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Hefiya",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Hukyndra",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Hulio",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hulio",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Humira",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/humira",
      "status": "Authorised",
      "kind": "reference"
     },
     {
      "name": "Hyrimoz",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Idacio",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/idacio",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Imraldi",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Libmyris",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Yuflyma",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Cyltezo",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo",
      "status": "Withdrawn",
      "kind": "biosimilar"
     },
     {
      "name": "Fyzoclad",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/fyzoclad",
      "status": "Application withdrawn",
      "kind": "reference"
     },
     {
      "name": "Halimatoz",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz",
      "status": "Withdrawn",
      "kind": "biosimilar"
     },
     {
      "name": "Kromeya",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya",
      "status": "Withdrawn",
      "kind": "biosimilar"
     },
     {
      "name": "Solymbic",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic",
      "status": "Withdrawn",
      "kind": "biosimilar"
     }
    ],
    "FR": [
     {
      "name": "AMGEVITA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68619482/extrait",
      "products": 5
     },
     {
      "name": "AMSPARITY",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62720332/extrait",
      "products": 2
     },
     {
      "name": "HUKYNDRA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68799977/extrait",
      "products": 4
     },
     {
      "name": "HULIO",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64158422/extrait",
      "products": 3
     },
     {
      "name": "HUMIRA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62975984/extrait",
      "products": 5
     },
     {
      "name": "HYRIMOZ",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64974404/extrait",
      "products": 5
     },
     {
      "name": "IDACIO",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65837903/extrait",
      "products": 2
     },
     {
      "name": "IMRALDI",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64844542/extrait",
      "products": 2
     },
     {
      "name": "LIBMYRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65973337/extrait",
      "products": 4
     },
     {
      "name": "YUFLYMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65075488/extrait",
      "products": 5
     }
    ],
    "ES": [],
    "UK": [
     {
      "name": "Humira",
      "url": "https://dmd-browser.nhsbsa.nhs.uk/ampp/view/152789",
      "supplier": "AbbVie Ltd"
     },
     {
      "name": "Amgevita HCF",
      "url": "https://dmd-browser.nhsbsa.nhs.uk/ampp/view/201571",
      "supplier": "Amgen Ltd"
     },
     {
      "name": "Hyrimoz",
      "url": "https://dmd-browser.nhsbsa.nhs.uk/ampp/view/197776",
      "supplier": "Sandoz Ltd"
     },
     {
      "name": "Imraldi",
      "url": "https://dmd-browser.nhsbsa.nhs.uk/ampp/view/199558",
      "supplier": "Biogen Idec Ltd"
     },
     {
      "name": "Yuflyma",
      "url": "https://dmd-browser.nhsbsa.nhs.uk/ampp/view/184665",
      "supplier": "Celltrion Healthcare UK Ltd"
     }
    ],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  },
  "letrozole": {
   "atc": "L02BG04",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-14424",
     "date": "2015-12-02",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_2583139",
     "products": [
      "FEMARA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par FEMARA est important dans le traitement néoadjuvant chez la femme ménopausée avec des récepteurs hormonaux positifs présentant un cancer du sein HER-2 négatif lorsque la chimiothérapie n’est pas adaptée et que la chirurgie immédiate n’est pas indiquée."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Compte tenu de la transposabilité non assurée des données issues de l’étude pivot en raison de l’absence de prise en compte du statut HER2 et de l’éligibilité à la chimiothérapie dans l’inclusion des patientes, la Commission considère que FEMARA n’apporte pas d’Amélioration du Service Médical Rendu (ASMR V) par rapport à la stratégie actuelle de prise en charge de ces patientes."
      }
     ]
    },
    {
     "dossier": "CT-14362",
     "date": "2015-12-02",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2583124",
     "products": [
      "FEMARA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par FEMARA reste important dans :\n• le traitement adjuvant du cancer du sein invasif à un stade précoce chez la femme ménopausée avec des récepteurs hormonaux positifs .\n• la prolongation du traitement adjuvant du cancer du sein hormono-dépendant invasif chez la femme ménopausée ayant préalablement reçu un traitement adjuvant standard par le tamoxifène pendant 5 ans .\n• le traitement de première intention du cancer du sein hormono-dépendant à un stade avancé chez la femme ménopausée .\n• et le traitement du cancer du sein à un stade avancé après rechute ou progression de la maladie chez la femme ménopausée (statut endocrinien de ménopause naturelle ou artificielle) ayant été préalablement traitée par des antiestrogènes."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-3754",
     "date": "2007-01-03",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_487065",
     "products": [
      "FEMARA"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "III",
       "label": "FEMARA partage avec ARIMIDEX une ASMR modérée (de niveau III) en termes d'efficacité et de tolérance par rapport au tamoxifène dans l'indication traitement adjuvant du cancer du sein à un stade précoce chez la femme ménopausée."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "FEMARA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64492112/extrait",
      "products": 4
     },
     {
      "name": "LETROZOLE ACCORD HEALTHCARE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69489312/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE ALMUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67399300/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE ARROW LAB",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60293216/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE BIOGARAN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66935695/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE CRISTERS PHARMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65035967/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE EG",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60791099/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE EVOLUGEN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64849151/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE SANDOZ",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65224722/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE TEVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65478037/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE VIATRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66801276/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE ZENTIVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69034542/extrait",
      "products": 1
     },
     {
      "name": "LETROZOLE ZYDUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63255320/extrait",
      "products": 1
     }
    ],
    "ES": [
     {
      "name": "FEMARA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/837871425042018IP/FT_837871425042018IP.html",
      "products": 6,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "GALDAR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/71058/FT_71058.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL ACCORD",
      "url": "https://cima.aemps.es/cima/dochtml/ft/70745/FT_70745.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL ALMUS PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/83555/FT_83555.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL ALTER",
      "url": "https://cima.aemps.es/cima/dochtml/ft/72124/FT_72124.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL AUROVITAS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/85626/FT_85626.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL BLUEFISH",
      "url": "https://cima.aemps.es/cima/dochtml/ft/74858/FT_74858.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL CINFA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/72125/FT_72125.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL COMBIX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/74256/FT_74256.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL DR. REDDYS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/72683/FT_72683.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL EDIGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/70854/FT_70854.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL KERN PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/71661/FT_71661.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL MABO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/84689/FT_84689.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL NORMON",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69862/FT_69862.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL PENSA PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/81743/FT_81743.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL SANDOZ",
      "url": "https://cima.aemps.es/cima/dochtml/ft/70933/FT_70933.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL STADA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/689730000/FT_689730000.html",
      "products": 2,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL TARBIS FARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/85894/FT_85894.html",
      "products": 2,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL TECNIGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/70995/FT_70995.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL TEVAGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/72500/FT_72500.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LETROZOL VIATRIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/73315/FT_73315.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "LOXIFAN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/62079/FT_62079.html",
      "products": 1,
      "atc": [
       "L02BG04"
      ]
     },
     {
      "name": "SYBALI",
      "url": "https://cima.aemps.es/cima/dochtml/ft/89215/FT_89215.html",
      "products": 2,
      "atc": [
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     }
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    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
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    "UK": "uk-dmd",
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      {
       "value": "V",
       "label": "Dans l'extension d’indication Prévention des événements coronaires et cérébrovasculaires chez des patients diabétiques de type 2 avec un autre facteur de risque, avec ou sans hyperlipidémie associée, l’atorvastatine à la posologie de 10 mg/j partage avec la simvastatine 40 mg/j la même amélioration du service médical rendu : pas d'amélioration du service médical rendu majeure (ASMR V), chez le coronarien, indépendamment du niveau du cholestérol."
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     {
      "name": "ATORVASTATINE EVOLUGEN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63661449/extrait",
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     {
      "name": "ATORVASTATINE HCS",
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     {
      "name": "ATORVASTATINE SANDOZ",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68556498/extrait",
      "products": 4
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     {
      "name": "ATORVASTATINE TEVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66012462/extrait",
      "products": 4
     },
     {
      "name": "ATORVASTATINE VIATRIS SANTE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60318089/extrait",
      "products": 4
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     {
      "name": "ATORVASTATINE ZENTIVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62866294/extrait",
      "products": 4
     },
     {
      "name": "ATORVASTATINE ZYDUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65584300/extrait",
      "products": 4
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     {
      "name": "ATORVASTATINE ZYDUS FRANCE",
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     {
      "name": "TAHOR",
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     {
      "name": "ATORIS",
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     },
     {
      "name": "ATORVASTATINA ABEX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/82601/FT_82601.html",
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      "atc": [
       "C10AA05"
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     },
     {
      "name": "ATORVASTATINA ALMUS PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/82627/FT_82627.html",
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      "atc": [
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     },
     {
      "name": "ATORVASTATINA ALTER GENERICOS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/85904/FT_85904.html",
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      "atc": [
       "C10AA05"
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     },
     {
      "name": "ATORVASTATINA AUROVITAS PHARMA",
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     },
     {
      "name": "ATORVASTATINA BLUEFISH",
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     },
     {
      "name": "ATORVASTATINA CINFA",
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     },
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      "name": "ATORVASTATINA COMBIX",
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     {
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     },
     {
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     },
     {
      "name": "ATORVASTATINA KERN PHARMA",
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      "atc": [
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     },
     {
      "name": "ATORVASTATINA KRKA",
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     },
     {
      "name": "ATORVASTATINA MABO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/72283/FT_72283.html",
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     },
     {
      "name": "ATORVASTATINA NORMOGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/86796/FT_86796.html",
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      "atc": [
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     },
     {
      "name": "ATORVASTATINA NORMON",
      "url": "https://cima.aemps.es/cima/dochtml/ft/87270/FT_87270.html",
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     },
     {
      "name": "ATORVASTATINA OPKO",
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     {
      "name": "ATORVASTATINA PENSA PHARMA",
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     },
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     },
     {
      "name": "ATORVASTATINA QUALIGEN FARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/82890/FT_82890.html",
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      "atc": [
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     },
     {
      "name": "ATORVASTATINA QUALIGEN PHARMA",
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     },
     {
      "name": "ATORVASTATINA SANDOZ",
      "url": "https://cima.aemps.es/cima/dochtml/ft/86611/FT_86611.html",
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      "atc": [
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     },
     {
      "name": "ATORVASTATINA STADAGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/80728/FT_80728.html",
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      "atc": [
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     },
     {
      "name": "ATORVASTATINA SUN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/76533/FT_76533.html",
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     },
     {
      "name": "ATORVASTATINA TARBIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/73827/FT_73827.html",
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     },
     {
      "name": "ATORVASTATINA TARBIS FARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/86451/FT_86451.html",
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     },
     {
      "name": "ATORVASTATINA TECNIGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69497/FT_69497.html",
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     },
     {
      "name": "ATORVASTATINA TEVA-RATIO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/89922/FT_89922.html",
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     },
     {
      "name": "ATORVASTATINA VIATRIS",
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     },
     {
      "name": "ATORVASTATINA VIR PHARMA",
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     },
     {
      "name": "ATORVASTATINA ZENTIVA LAB",
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     },
     {
      "name": "ATORVATATINA TECNIGEN",
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     },
     {
      "name": "CARDYL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/61716/FT_61716.html",
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     },
     {
      "name": "PREVENCOR",
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     },
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      "name": "THERVAN",
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     {
      "name": "METFORMINE VIATRIS",
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     {
      "name": "METFORMINE ZENTIVA",
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     {
      "name": "METFORMINE ZENTIVA K.S.",
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     {
      "name": "METFORMINE ZYDUS",
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     {
      "name": "METFORMINE ZYDUS FRANCE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68319595/extrait",
      "products": 1
     },
     {
      "name": "STAGID",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61232102/extrait",
      "products": 1
     }
    ],
    "ES": [
     {
      "name": "BROTMIN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/85976/FT_85976.html",
      "products": 2,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA ALMUS PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/83166/FT_83166.html",
      "products": 3,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA ALTER",
      "url": "https://cima.aemps.es/cima/dochtml/ft/89135/FT_89135.html",
      "products": 1,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA AUROVITAS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/74969/FT_74969.html",
      "products": 1,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA CINFA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68167/FT_68167.html",
      "products": 1,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA KERN PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/83863/FT_83863.html",
      "products": 3,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA PENSA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/88536/FT_88536.html",
      "products": 1,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA PHARMA COMBIX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/89110/FT_89110.html",
      "products": 3,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA SANDOZ",
      "url": "https://cima.aemps.es/cima/dochtml/ft/82700/FT_82700.html",
      "products": 2,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA STADAFARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/88809/FT_88809.html",
      "products": 5,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA TARBIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/76584/FT_76584.html",
      "products": 2,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA TEVA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/89277/FT_89277.html",
      "products": 3,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA UXA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/83248/FT_83248.html",
      "products": 2,
      "atc": [
       "A10BA02"
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     },
     {
      "name": "METFORMINA VIATRIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/72222/FT_72222.html",
      "products": 2,
      "atc": [
       "A10BA02"
      ]
     },
     {
      "name": "METFORMINA VIR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/83866/FT_83866.html",
      "products": 1,
      "atc": [
       "A10BA02"
      ]
     }
    ],
    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  },
  "amlodipine": {
   "atc": "C08CA01",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-15535",
     "date": "2016-11-09",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2725188",
     "products": [
      "AMLOR"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par AMLOR reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "AMLODIPINE ALMUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69622809/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE ARROW",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62514791/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE BIOGARAN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68158195/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE CRISTERS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64891741/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE EG",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69923011/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE EVOLUGEN PHARMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68688222/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE KRKA D.D",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68841796/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE SANDOZ",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68096904/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE TEVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69066650/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE VIATRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63657486/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE ZENTIVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62920265/extrait",
      "products": 2
     },
     {
      "name": "AMLODIPINE ZYDUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68500357/extrait",
      "products": 2
     },
     {
      "name": "AMLOR",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61939921/extrait",
      "products": 2
     }
    ],
    "ES": [
     {
      "name": "AMLODIPINO ALTER",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65082/FT_65082.html",
      "products": 3,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO ALMUS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/70751/FT_70751.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO AUROVITAS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/81645/FT_81645.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO BD-MABO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/71582/FT_71582.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO BLUEFISH",
      "url": "https://cima.aemps.es/cima/dochtml/ft/72686/FT_72686.html",
      "products": 1,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO CINFA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65461/FT_65461.html",
      "products": 3,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO COMBIX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/72814/FT_72814.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO KERN PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65467/FT_65467.html",
      "products": 3,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO MABO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/85521/FT_85521.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO NORMON",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68311/FT_68311.html",
      "products": 3,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO ORTODROL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69813/FT_69813.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO PENSA PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/84263/FT_84263.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO RATIOPHARM",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68426/FT_68426.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO SANDOZ",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68761/FT_68761.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO STADA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/79471/FT_79471.html",
      "products": 1,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO STADA GENERICOS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/79470/FT_79470.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO TAD",
      "url": "https://cima.aemps.es/cima/dochtml/ft/87993/FT_87993.html",
      "products": 3,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO TARBIS FARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/84863/FT_84863.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO TECNIGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69167/FT_69167.html",
      "products": 3,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO TEVA-RATIOPHARM",
      "url": "https://cima.aemps.es/cima/dochtml/ft/90903/FT_90903.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO TEVAGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/75710/FT_75710.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO VIR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68422/FT_68422.html",
      "products": 3,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "AMLODIPINO VIR-PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69962/FT_69962.html",
      "products": 1,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "ASTUDAL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/59161/FT_59161.html",
      "products": 2,
      "atc": [
       "C08CA01"
      ]
     },
     {
      "name": "ZABART",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69940/FT_69940.html",
      "products": 3,
      "atc": [
       "C08CA01"
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     }
    ],
    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  },
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   "atc": "A02BC01",
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    {
     "dossier": "CT-18424",
     "date": "2020-09-16",
     "motif": "Réévaluation SMR et ASMR",
     "url": "https://www.has-sante.fr/jcms/p_3215555",
     "products": [
      "OMEPRAZOLE VIATRIS"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par OMEPRAZOLE MYLAN reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-18392",
     "date": "2020-09-16",
     "motif": "Réévaluation SMR et ASMR",
     "url": "https://www.has-sante.fr/jcms/p_3215585",
     "products": [
      "OMEPRAZOLE ARROW"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par OMEPRAZOLE ARROW reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-18382",
     "date": "2020-09-16",
     "motif": "Réévaluation SMR et ASMR",
     "url": "https://www.has-sante.fr/jcms/p_3215588",
     "products": [
      "MOPRAL",
      "ZOLTUM"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par MOPRAL et ZOLTUM reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-17452",
     "date": "2019-01-23",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2901467",
     "products": [
      "OMEPRAZOLE CRISTERS PHARMA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par OMEPRAZOLE CRISTERS 20 mg, gélule gastro-résistante est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un générique qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport au princeps."
      }
     ]
    },
    {
     "dossier": "CT-14955",
     "date": "2016-03-02",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2617865",
     "products": [
      "OMEPRAZOLE EG"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par OMEPRAZOLE EG 20 mg, gélule gastro-résistante est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un générique qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport au princeps."
      }
     ]
    },
    {
     "dossier": "CT-14638",
     "date": "2015-09-16",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2559097",
     "products": [
      "MOPRAL"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par MOPRAL 10 mg (B/30) et MOPRAL 20 mg (B/30) est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-14637",
     "date": "2015-09-16",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2559088",
     "products": [
      "ZOLTUM"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par ZOLTUM 10 mg (B/30) et ZOLTUM 20 mg (B/30) est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-14284",
     "date": "2015-09-16",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2559100",
     "products": [
      "MOPRAL",
      "ZOLTUM"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par MOPRAL et ZOLTUM reste important dans l’ensemble des indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-9836",
     "date": "2011-02-02",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "OMEPRAZOLE ARROW"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par OMEPRAZOLE ARROW 40 mg, solution pour perfusion est important dans l'indication de l'AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d'amélioration du service médical rendu (ASMR V) par rapport aux autres spécialités à base d'oméprazole ayant les mêmes indications."
      }
     ]
    },
    {
     "dossier": "CT-6172",
     "date": "2009-01-07",
     "motif": "Réévaluation SMR",
     "url": "https://www.has-sante.fr/jcms/c_763732",
     "products": [
      "ZOLTUM"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Le niveau d'amélioration du service médical rendu est maintenu pour ZOLTUM dans les indications de l'AMM, chez l'adulte."
      }
     ]
    },
    {
     "dossier": "CT-6171",
     "date": "2009-01-07",
     "motif": "Réévaluation SMR",
     "url": "https://www.has-sante.fr/jcms/c_763738",
     "products": [
      "MOPRAL"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "Commentaires sans chiffrage de l'ASMR",
       "label": "Le niveau d'amélioration du service médical rendu est maintenu pour MOPRAL dans les indications de l'AMM, chez l'adulte."
      }
     ]
    },
    {
     "dossier": "CT-4314",
     "date": "2007-02-28",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "OMEPRAZOLE VIATRIS"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par cette spécialité est important dans les indications de l'AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d’amélioration du service médical rendu."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "MOPRAL",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69606819/extrait",
      "products": 2
     },
     {
      "name": "MOPRALPRO",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62044256/extrait",
      "products": 1
     },
     {
      "name": "OMEPRAZOLE ALMUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68605333/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE ARROW",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61123131/extrait",
      "products": 3
     },
     {
      "name": "OMEPRAZOLE ARROW CONSEIL",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69816753/extrait",
      "products": 1
     },
     {
      "name": "OMEPRAZOLE ARROW LAB",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64997342/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE BIOGARAN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67450136/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE BIOGARAN CONSEIL",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61193553/extrait",
      "products": 1
     },
     {
      "name": "OMEPRAZOLE CRISTERS PHARMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65830008/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE EG",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69503071/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE EVOLUGEN PHARMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65204851/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE KRKA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60860606/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE SANDOZ",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68748071/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE SANDOZ CONSEIL",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68995940/extrait",
      "products": 1
     },
     {
      "name": "OMEPRAZOLE TEVA CONSEIL",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65231460/extrait",
      "products": 1
     },
     {
      "name": "OMEPRAZOLE TEVA PHARMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65581090/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE VIATRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62543615/extrait",
      "products": 3
     },
     {
      "name": "OMEPRAZOLE VIATRIS CONSEIL",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69036504/extrait",
      "products": 1
     },
     {
      "name": "OMEPRAZOLE ZENTIVA CONSEIL",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65728544/extrait",
      "products": 1
     },
     {
      "name": "OMEPRAZOLE ZENTIVA LAB",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69531932/extrait",
      "products": 2
     },
     {
      "name": "OMEPRAZOLE ZYDUS FRANCE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67575816/extrait",
      "products": 2
     },
     {
      "name": "ZOLTUM",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69276588/extrait",
      "products": 2
     }
    ],
    "ES": [
     {
      "name": "ARAPRIDE",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65687/FT_65687.html",
      "products": 3,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "AULCER",
      "url": "https://cima.aemps.es/cima/dochtml/ft/58786/FT_58786.html",
      "products": 1,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "BELMAZOL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/59829/FT_59829.html",
      "products": 2,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "DOLINTOL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65823/FT_65823.html",
      "products": 6,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "GASTRIMUT",
      "url": "https://cima.aemps.es/cima/dochtml/ft/59842/FT_59842.html",
      "products": 2,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "NUCLOSINA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/60484/FT_60484.html",
      "products": 1,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMAPREN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/58382/FT_58382.html",
      "products": 1,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL KERN PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/63301/FT_63301.html",
      "products": 5,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL ALMUS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/67531/FT_67531.html",
      "products": 8,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL ALTER",
      "url": "https://cima.aemps.es/cima/dochtml/ft/81297/FT_81297.html",
      "products": 4,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL AUROVITAS SPAIN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/72145/FT_72145.html",
      "products": 6,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL CINFA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/63983/FT_63983.html",
      "products": 5,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL CINFAMED",
      "url": "https://cima.aemps.es/cima/dochtml/ft/62764/FT_62764.html",
      "products": 4,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL COMBIX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69139/FT_69139.html",
      "products": 3,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL DAVUR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65519/FT_65519.html",
      "products": 4,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL GOBENS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/81391/FT_81391.html",
      "products": 11,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL KORHISPANA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65186/FT_65186.html",
      "products": 1,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL KRKA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/64492/FT_64492.html",
      "products": 2,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL MABO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/79979/FT_79979.html",
      "products": 7,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL NORMON",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69233/FT_69233.html",
      "products": 6,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL PENSA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/62757/FT_62757.html",
      "products": 9,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL QUALIGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68793/FT_68793.html",
      "products": 2,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL SANDOZ FARMACEUTICA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65517/FT_65517.html",
      "products": 8,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL STADA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/63908/FT_63908.html",
      "products": 7,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL SUN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/74958/FT_74958.html",
      "products": 1,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL TARBIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/64375/FT_64375.html",
      "products": 6,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL TARBIS FARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69212/FT_69212.html",
      "products": 8,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL TECNIMEDE",
      "url": "https://cima.aemps.es/cima/dochtml/ft/63916/FT_63916.html",
      "products": 4,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL TEVA- RATIO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69124/FT_69124.html",
      "products": 10,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL VIATRIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/62763/FT_62763.html",
      "products": 3,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "OMEPRAZOL VIR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65095/FT_65095.html",
      "products": 8,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "PARIZAC",
      "url": "https://cima.aemps.es/cima/dochtml/ft/58466/FT_58466.html",
      "products": 2,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "PEPTICUM",
      "url": "https://cima.aemps.es/cima/dochtml/ft/58428/FT_58428.html",
      "products": 3,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "ULCERAL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/81271/FT_81271.html",
      "products": 2,
      "atc": [
       "A02BC01"
      ]
     },
     {
      "name": "ULCESEP",
      "url": "https://cima.aemps.es/cima/dochtml/ft/58787/FT_58787.html",
      "products": 1,
      "atc": [
       "A02BC01"
      ]
     }
    ],
    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  },
  "levothyroxine": {
   "atc": "H03AA01",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-21127",
     "date": "2024-11-20",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3565869",
     "products": [
      "LEVOTHYROX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVOTHYROX (lévothyroxine sodique) est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-19762",
     "date": "2023-03-08",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3421152",
     "products": [
      "TSOLUDOSE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par TSOLUDOSE (lévothyroxine sodique) est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Compte tenu :\n• du recul sur l’efficacité et la tolérance de la lévothyroxine sodique,\n• des données disponibles avec TSOLUDOSE (lévothyroxine sodique) reposant uniquement sur des études de bioéquivalence et de biodisponibilité, qui ne permettent pas d’évaluer un éventuel avantage de TSOLUDOSE (lévothyroxine sodique) par rapport aux alternatives à base de lévothyroxine disponibles en France,\n• de l’absence de données robustes concernant la qualité de vie des patients traités par la solution buvable en unidose TSOLUDOSE (lévothyroxine sodique) comparativement aux alternatives à base de lévothyroxine sodique disponibles en France,\n• du besoin médical de disposer de nouvelles alternatives à base de lévothyroxine sodique en raison notamment de la marge thérapeutique étroite de cette molécule et de la nécessité d’un ajustement posologique individuel des traitements,\n• du choix restreint des dosages disponibles avec TSOLUDOSE (lévothyroxine sodique) limitant les possibilités d’adaptation de la posologie, ce qui représente une contrainte à prendre en compte lors de l’instauration d’un traitement par TSOLUDOSE (lévothyroxine sodique), en particulier chez le nouveau-né,\nla Commission de la transparence considère que TSOLUDOSE (lévothyroxine sodique) n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie thérapeutique."
      }
     ]
    },
    {
     "dossier": "CT-18933",
     "date": "2020-11-18",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3220952",
     "products": [
      "L-THYROXIN HENNING"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par L-THYROXIN HENNING comprimé sécable pour les 4 dosages 63, 88, 112, et 137 microgrammes, est important dans l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont un complément de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-18342",
     "date": "2020-03-20",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3166662",
     "products": [
      "THYROFIX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par THYROFIX 13 microgrammes, comprimé et THYROFIX 62 microgrammes, comprimé est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des hybrides qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-18351",
     "date": "2020-03-11",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3164095",
     "products": [
      "THYROFIX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par THYROFIX 25 - 50 - 75 et 100 microgrammes, comprimé est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des génériques qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport à la spécialité de référence."
      }
     ]
    },
    {
     "dossier": "CT-18177",
     "date": "2019-12-04",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3136106",
     "products": [
      "LEVOTHYROX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVOTHYROX est important dans l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-17274",
     "date": "2019-06-12",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3098026",
     "products": [
      "L-THYROXINE SERB"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par de L-THYROXINE SERB 150 µg/ml, solution buvable en gouttes reste important dans le traitement de toutes les hypothyroïdies d'origine haute ou basse, qu'elles soient complètes ou incomplètes ainsi que dans le traitement de toutes les circonstances, associées ou non à une hypothyroïdie, où l'on désire freiner la TSH."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-17311",
     "date": "2019-02-27",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2908493",
     "products": [
      "TCAPS"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par TCAPS est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Prenant en compte :\n• l’efficacité connue de la lévothyroxine,\n• le faible niveau de preuve des études réalisées avec TCAPS, qui ne permettent pas d’évaluer un éventuel effet clinique supplémentaire de TCAPS (lévothyroxine capsule molle) par rapport aux alternatives à base de lévothyroxine disponibles en France,\n• l’absence de données disponibles concernant la qualité de vie des patients traités par TCAPS par rapport à ceux traités par les alternatives à base de lévothyroxine disponibles en France,\n• le besoin médical de disposer de nouvelles alternatives à base de lévothyroxine en raison de la marge thérapeutique étroite de cette molécule et de la nécessité d’un ajustement posologique individuel des traitements,\nla Commission considère que les spécialités TCAPS n’apportent pas d’amélioration du service médical rendu (ASMR V) dans la stratégie thérapeutique actuelle qui comprend les comparateurs cliniquement pertinents (cf. paragraphe 06.1)."
      }
     ]
    },
    {
     "dossier": "CT-17405",
     "date": "2018-12-05",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2892918",
     "products": [
      "LEVOTHYROX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVOTHYROX 88 µg, 112 µg et 137 µg est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-16809",
     "date": "2018-02-07",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2834699",
     "products": [
      "L-THYROXIN HENNING"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités L-THYROXIN HENNING est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux spécialités à base de lévothyroxine déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-16604",
     "date": "2017-12-13",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2819626",
     "products": [
      "LEVOTHYROX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVOTHYROX 75 µg, 100 µg, 125 µg, 150 µg, 175 µg, 200 µg comprimé sécable est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-16064",
     "date": "2017-03-22",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2754737",
     "products": [
      "LEVOTHYROX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par ces nouvelles présentations de LEVOTHYROX est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces présentations sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-14129",
     "date": "2015-09-23",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2561570",
     "products": [
      "LEVOTHYROX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVOTHYROX reste important dans :\n• le traitement des hypothyroïdies,\n• le traitement des circonstances, associées ou non à une hypothyroïdie, où l'on désire freiner la TSH."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-7975",
     "date": "2010-04-28",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "LEVOTHYROX"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d'amélioration du service médical rendu (ASMR V)."
      }
     ]
    },
    {
     "dossier": "CT-7943",
     "date": "2010-03-10",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "LEVOTHYROX"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d’amélioration du service médical rendu (ASMR V)."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "L-THYROXIN HENNING",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62127264/extrait",
      "products": 12
     },
     {
      "name": "L-THYROXINE SERB",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65532702/extrait",
      "products": 2
     },
     {
      "name": "LEVOTHYROX",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68416845/extrait",
      "products": 13
     },
     {
      "name": "TCAPS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69288373/extrait",
      "products": 14
     },
     {
      "name": "THYROFIX",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64635603/extrait",
      "products": 13
     }
    ],
    "ES": [
     {
      "name": "EUTIROX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/64018/FT_64018.html",
      "products": 13,
      "atc": [
       "H03AA01"
      ]
     },
     {
      "name": "LEVOTIROXINA ARISTO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/84484/FT_84484.html",
      "products": 11,
      "atc": [
       "H03AA01"
      ]
     },
     {
      "name": "LEVOTIROXINA SANOFI",
      "url": "https://cima.aemps.es/cima/dochtml/ft/77802/FT_77802.html",
      "products": 3,
      "atc": [
       "H03AA01"
      ]
     },
     {
      "name": "LEVOTIROXINA SODICA TEVA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/77045/FT_77045.html",
      "products": 12,
      "atc": [
       "H03AA01"
      ]
     }
    ],
    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  },
  "sertraline": {
   "atc": "N06AB06",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-7400",
     "date": "2013-03-20",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_1525539",
     "products": [
      "ZOLOFT"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu de ZOLOFT 25 et 50 mg reste important :\n• dans l’indication prévention des récidives d’épisodes dépressifs majeurs de l’adulte\n• dans les épisodes dépressifs majeurs de l’adulte\n• dans les Troubles obsessionnels compulsifs de l'adulte ainsi que chez les enfants âgés de 6\nà 17 ans\n• dans le trouble panique, avec ou sans agoraphobie de l’adulte\n• dans l’état de stress post-traumatique de l’adulte"
      },
      {
       "value": "Modéré",
       "label": "Le service médical rendu par ZOLOFT 25 et 50mg est modéré dans le Trouble Anxiété Sociale de l’adulte."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Dans le trouble panique avec ou sans agoraphobie, le trouble anxiété sociale et l’état de stress post-traumatique, ZOLOFT n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres médicaments disponibles dans ces indications."
      }
     ]
    },
    {
     "dossier": "CT-77",
     "date": "2003-10-29",
     "motif": "Extension d'indication",
     "url": null,
     "products": [
      "ZOLOFT"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "III",
       "label": "Chez les patients souffrant de dépression unipolaire et ayant présenté au moins 3 récidives dépressives en 4 ans, l’amélioration du service médical rendu est modérée (niveau III) en terme d’efficacité par rapport aux pratiques usuelles."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "SERTRALINE ALMUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68728154/extrait",
      "products": 1
     },
     {
      "name": "SERTRALINE ARROW LAB",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65090846/extrait",
      "products": 2
     },
     {
      "name": "SERTRALINE BIOGARAN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67019171/extrait",
      "products": 2
     },
     {
      "name": "SERTRALINE CRISTERS PHARMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62973200/extrait",
      "products": 2
     },
     {
      "name": "SERTRALINE EG",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61358656/extrait",
      "products": 1
     },
     {
      "name": "SERTRALINE EVOLUGEN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61323160/extrait",
      "products": 1
     },
     {
      "name": "SERTRALINE TEVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68462757/extrait",
      "products": 2
     },
     {
      "name": "SERTRALINE VIATRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66614337/extrait",
      "products": 2
     },
     {
      "name": "SERTRALINE ZENTIVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67392284/extrait",
      "products": 2
     },
     {
      "name": "SERTRALINE ZYDUS FRANCE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66544294/extrait",
      "products": 2
     },
     {
      "name": "ZOLOFT",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60155788/extrait",
      "products": 2
     }
    ],
    "ES": [
     {
      "name": "ALTISBEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65925/FT_65925.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "AREMIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/59734/FT_59734.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "BESITRAN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/59718/FT_59718.html",
      "products": 3,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SEMONIC",
      "url": "https://cima.aemps.es/cima/dochtml/ft/84190/FT_84190.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA ALTER",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65927/FT_65927.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA ALMUS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/69766/FT_69766.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA AUROVITAS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/82449/FT_82449.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA CINFA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66057/FT_66057.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA CUVE",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65998/FT_65998.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA DAVUR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65947/FT_65947.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA KERN PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65971/FT_65971.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA MABO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65969/FT_65969.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA NORMON",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65922/FT_65922.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA PENSA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68391/FT_68391.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA PHARMA COMBIX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/74389/FT_74389.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA QUALIGEN FARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66117/FT_66117.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA SANDOZ FARMACEUTICA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66170/FT_66170.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA STADA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65929/FT_65929.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA SUN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66016/FT_66016.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA TARBIS FARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/86818/FT_86818.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA TECNIGEN",
      "url": "https://cima.aemps.es/cima/dochtml/ft/68170/FT_68170.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA TEVA-RATIO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66069/FT_66069.html",
      "products": 4,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA VIATRIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65645/FT_65645.html",
      "products": 1,
      "atc": [
       "N06AB06"
      ]
     },
     {
      "name": "SERTRALINA VIR PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66111/FT_66111.html",
      "products": 2,
      "atc": [
       "N06AB06"
      ]
     }
    ],
    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  },
  "amoxicillin": {
   "atc": "J01CA04",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-19423",
     "date": "2021-09-08",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3287341",
     "products": [
      "XYLLOMAC"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités CLAMOXYL (amoxicilline) 500 mg et 1 g, poudre pour solution injectable/ pour perfusion (IM, IV) est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-17504",
     "date": "2019-01-09",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2899634",
     "products": [
      "AMOXICILLINE ARROW LAB"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par AMOXICILLINE ARROW LAB 1 g, comprimé dispersible est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un générique qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport au princeps CLAMOXYL 1 g, comprimé dispersible."
      }
     ]
    },
    {
     "dossier": "CT-14821",
     "date": "2016-04-06",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2624081",
     "products": [
      "XYLLOMAC"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par CLAMOXYL 1 g poudre pour solution injectable (IM, IV) est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-14820",
     "date": "2016-04-06",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2624075",
     "products": [
      "CLAMOXYL"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par CLAMOXYL reste important dans toutes les indications, excepté dans les surinfections de bronchites aiguës."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par CLAMOXYL reste insuffisant dans les surinfections de bronchites aiguës."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-14631",
     "date": "2015-09-23",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2563024",
     "products": [
      "AMOXICILLINE ARROW LAB"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par AMOXICILLINE ARROW LAB 500 mg, gélule, est important dans toutes les autres indications de l’AMM."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par AMOXICILLINE ARROW LAB 500 mg, gélule, est insuffisant dans le traitement des surinfections des bronchites aiguës."
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     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un générique qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport au princeps CLAMOXYL 500 mg, gélule."
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     ]
    },
    {
     "dossier": "CT-11890",
     "date": "2012-02-29",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "AMOXICILLINE ARROW"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par ces spécialités est important dans les indications de l'AMM, excepté dans l'indication « surinfections de bronchites aiguës » pour laquelle le service médical rendu est insuffisant."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par ces spécialités est insuffisant dans l'indication « surinfections de bronchites aiguës »."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n'apportent pas d'amélioration du service médical rendu (ASMR V)."
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     ]
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "AMOXICILLINE ALMUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60151544/extrait",
      "products": 1
     },
     {
      "name": "AMOXICILLINE ALMUS PHARMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68695334/extrait",
      "products": 1
     },
     {
      "name": "AMOXICILLINE ARROW",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61771313/extrait",
      "products": 3
     },
     {
      "name": "AMOXICILLINE ARROW LAB",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69166540/extrait",
      "products": 2
     },
     {
      "name": "AMOXICILLINE BENTA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67459306/extrait",
      "products": 1
     },
     {
      "name": "AMOXICILLINE BGR",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66511789/extrait",
      "products": 1
     },
     {
      "name": "AMOXICILLINE BIOGARAN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60366319/extrait",
      "products": 4
     },
     {
      "name": "AMOXICILLINE CRISTERS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69489433/extrait",
      "products": 2
     },
     {
      "name": "AMOXICILLINE EG",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62457618/extrait",
      "products": 1
     },
     {
      "name": "AMOXICILLINE EG LABO",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68116292/extrait",
      "products": 3
     },
     {
      "name": "AMOXICILLINE EVOLUGEN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68607010/extrait",
      "products": 3
     },
     {
      "name": "AMOXICILLINE KRKA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60101406/extrait",
      "products": 1
     },
     {
      "name": "AMOXICILLINE PANPHARMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66918105/extrait",
      "products": 3
     },
     {
      "name": "AMOXICILLINE SANDOZ",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64672103/extrait",
      "products": 5
     },
     {
      "name": "AMOXICILLINE TEVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65253528/extrait",
      "products": 1
     },
     {
      "name": "AMOXICILLINE TEVA SANTE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65158724/extrait",
      "products": 4
     },
     {
      "name": "AMOXICILLINE VIATRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64489810/extrait",
      "products": 4
     },
     {
      "name": "AMOXICILLINE VIATRIS PHARMA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64470824/extrait",
      "products": 1
     },
     {
      "name": "AMOXICILLINE VIATRIS SANTE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64960301/extrait",
      "products": 2
     },
     {
      "name": "AMOXICILLINE ZENTIVA LAB",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66628041/extrait",
      "products": 5
     },
     {
      "name": "AMOXICILLINE ZYDUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67587238/extrait",
      "products": 4
     },
     {
      "name": "AMOXICILLINE ZYDUS FRANCE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64727464/extrait",
      "products": 1
     },
     {
      "name": "CLAMOXYL",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64539416/extrait",
      "products": 5
     },
     {
      "name": "XYLLOMAC",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61801023/extrait",
      "products": 3
     }
    ],
    "ES": [
     {
      "name": "AMOXICILINA ALMUS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/81377/FT_81377.html",
      "products": 8,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA ALTER",
      "url": "https://cima.aemps.es/cima/dochtml/ft/83825/FT_83825.html",
      "products": 2,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA ARDINE",
      "url": "https://cima.aemps.es/cima/dochtml/ft/60524/FT_60524.html",
      "products": 15,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA AUROVITAS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/86025/FT_86025.html",
      "products": 6,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA CINFA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/62880/FT_62880.html",
      "products": 8,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA COMBIX",
      "url": "https://cima.aemps.es/cima/dochtml/ft/84016/FT_84016.html",
      "products": 2,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA NORMON",
      "url": "https://cima.aemps.es/cima/dochtml/ft/64390/FT_64390.html",
      "products": 14,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA PENSA PHARMA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/84172/FT_84172.html",
      "products": 6,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA RATIOPHARM",
      "url": "https://cima.aemps.es/cima/dochtml/ft/62118/FT_62118.html",
      "products": 4,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA SANDOZ",
      "url": "https://cima.aemps.es/cima/dochtml/ft/62340/FT_62340.html",
      "products": 7,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA SANDOZ FARMACEUTICA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/89319/FT_89319.html",
      "products": 2,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "AMOXICILINA TEVA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/66643/FT_66643.html",
      "products": 2,
      "atc": [
       "J01CA04"
      ]
     },
     {
      "name": "CLAMOXYL",
      "url": "https://cima.aemps.es/cima/dochtml/ft/59133/FT_59133.html",
      "products": 4,
      "atc": [
       "J01CA04"
      ]
     }
    ],
    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  },
  "salbutamol": {
   "atc": "R03AC02",
   "epar": [],
   "has_ct": [
    {
     "dossier": "CT-20854",
     "date": "2024-12-11",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3574253",
     "products": [
      "VENTOLINE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par VENTOLINE (salbutamol) 0,5 mg/1 ml, solution injectable par voie sous-cutanée en ampoule en boîte de 5, est important dans l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la présentation déjà inscrite."
      }
     ]
    },
    {
     "dossier": "CT-14644",
     "date": "2017-02-22",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2748403",
     "products": [
      "SALBUTAMOL VIATRIS"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par SALBUTAMOL MYLAN reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-15393",
     "date": "2016-11-09",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2724025",
     "products": [
      "VENTOLINE"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités VENTOLINE reste important dans les indications respectives de leur AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-14550",
     "date": "2015-09-23",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2561579",
     "products": [
      "AIROMIR AUTOHALER",
      "SALBUTAMOL TEVA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par AIROMIR AUTOHALER et SALBUTAMOL TEVA reste important dans les indications de l'AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-13770",
     "date": "2015-04-15",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2030571",
     "products": [
      "VENTILASTIN NOVOLIZER"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités VENTILASTIN NOVOLIZER 100 µg/dose, poudre pour inhalation reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-8544",
     "date": "2010-11-03",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "SALBUMOL FORT"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par cette spécialité est important."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n'apporte pas d'amélioration du service médical rendu (ASMR V)."
      }
     ]
    },
    {
     "dossier": "CT-5032",
     "date": "2007-09-12",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "SALBUTAMOL RENAUDIN"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par cette spécialité est important dans les indications de l'AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d’amélioration du service médical rendu."
      }
     ]
    },
    {
     "dossier": "CT-1295",
     "date": "2005-06-22",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_400347",
     "products": [
      "VENTOLINE"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "Commentaires sans chiffrage de l'ASMR",
       "label": "Dans la prise en charge de l’asthme aigu grave et des poussées aiguës de BPCO en ambulatoire, VENTOLINE solution pour inhalation par nébuliseur, conserve un intérêt thérapeutique important dans la prise en charge habituelle des patients."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [],
    "FR": [
     {
      "name": "AIROMIR AUTOHALER",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66086181/extrait",
      "products": 1
     },
     {
      "name": "SALBUMOL FORT",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63744069/extrait",
      "products": 1
     },
     {
      "name": "SALBUTAMOL ARROW",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68563941/extrait",
      "products": 2
     },
     {
      "name": "SALBUTAMOL RENAUDIN",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63266758/extrait",
      "products": 1
     },
     {
      "name": "SALBUTAMOL TEVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63883282/extrait",
      "products": 3
     },
     {
      "name": "SALBUTAMOL VIATRIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68174071/extrait",
      "products": 3
     },
     {
      "name": "VENTILASTIN NOVOLIZER",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65779001/extrait",
      "products": 1
     },
     {
      "name": "VENTOLINE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69077942/extrait",
      "products": 12
     }
    ],
    "ES": [
     {
      "name": "SALBUAIR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/73563/FT_73563.html",
      "products": 2,
      "atc": [
       "R03AC02"
      ]
     },
     {
      "name": "SALBUTAMOL ALDO-UNION",
      "url": "https://cima.aemps.es/cima/dochtml/ft/65850/FT_65850.html",
      "products": 1,
      "atc": [
       "R03AC02"
      ]
     },
     {
      "name": "VENTOALDO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/52404/FT_52404.html",
      "products": 1,
      "atc": [
       "R03AC02"
      ]
     }
    ],
    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  },
  "apixaban": {
   "atc": "B01AF02",
   "epar": [
    {
     "name": "Apixaban Accord",
     "number": "EMEA/H/C/005358",
     "status": "Authorised",
     "inn": "apixaban",
     "substance": "apixaban",
     "atc": [
      "B01AF02"
     ],
     "holder": "Accord Healthcare S.L.U.",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2020-07-23",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-07-27",
     "therapeutic_area": "Venous Thromboembolism;Stroke;Arthroplasty",
     "indication": "Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Adults Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/apixaban-accord"
    },
    {
     "name": "Eliquis",
     "number": "EMEA/H/C/002148",
     "status": "Authorised",
     "inn": "apixaban",
     "substance": "apixaban",
     "atc": [
      "B01AF02"
     ],
     "holder": "Bristol-Myers Squibb / Pfizer EEIG",
     "generic": false,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2011-05-18",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-04-01",
     "therapeutic_area": "Arthroplasty;Venous Thromboembolism",
     "indication": "Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eliquis"
    }
   ],
   "has_ct": [
    {
     "dossier": "CT-21145",
     "date": "2025-04-23",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3609208",
     "products": [
      "ELIQUIS"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par ELIQUIS (apixaban) est important dans la nouvelle indication de l’AMM « Traitement des événements thromboemboliques veineux (ETEV) et prévention de la récidive d’ETEV chez les patients pédiatriques âgés de 28 jours à moins de 18 ans »."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Prenant en compte :\n• les données d’efficacité d’apixaban en population pédiatrique, issues principalement d‘une étude clinique dont l’interprétation ne peut être que descriptive dans la mesure où aucune hypothèse statistique n’a été formulée, qui suggèrent une efficacité similaire à celle des traitements anticoagulants standards par héparine et/ou AVK dans le traitement des événements thromboemboliques veineux et la prévention de leur récidive,\n• les données de tolérance issues de cette étude, qui ne permettent pas d’exclure un risque de saignements mineurs plus élevé que sous traitement anticoagulant standard par héparine et/ou AVK,\n• le niveau de preuve de ces résultats qui reste limité,\n• le profil de tolérance globalement similaire à celui de la population adulte,\n• l’absence de données comparatives versus XARELTO (rivaroxaban), 1er AOD mis à disposition en France dans cette indication (comparaison directe non attendue compte tenu de leur développement concomitant),\n• les incertitudes sur son efficacité, sa tolérance et son utilisation à plus long terme en pratique courante, notamment chez les enfants les plus jeunes peu nombreux dans l’étude pivot,\n\nla Commission considère que ELIQUIS (apixaban) n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la prise en charge des événements thromboemboliques veineux dans la population pédiatrique après au moins 5 jours d’une anticoagulation parentérale initiale."
      }
     ]
    },
    {
     "dossier": "CT-16066",
     "date": "2018-01-24",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2826829",
     "products": [
      "ELIQUIS"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par ELIQUIS 2,5 et 5 mg reste important :\n• en prévention de l’AVC et de l’ES chez les patients ayant une FANV et présentant un ou plusieurs facteurs de risque.\n• dans le traitement de la thrombose veineuse profonde et de l’embolie pulmonaire et la prévention de leurs récidives chez l'adulte. La Commission souligne que les données disponibles (étude AMPLIFY) portent sur des patients ayant majoritairement reçu une HBPM, une HNF ou du fondaparinux à la phase aiguë (24-36ème heures) de l’événement thromboembolique veineux.\n• en prévention primaire des événements thromboemboliques veineux chez les patients adultes ayant bénéficié d'une chirurgie programmée pour prothèse totale de hanche ou de genou."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Les nouvelles données disponibles ne sont pas susceptibles de modifier l’appréciation précédente de la Commission, qui considère que les spécialités ELIQUIS n’apportent pas d’amélioration du service médical rendu (ASMR V) dans la stratégie thérapeutique de traitement de la thrombose veineuse profonde (TVP) et de l’embolie pulmonaire (EP) et la prévention de la récidive de TVP et d’EP chez l’adulte, qui comprend les AVK et les anticoagulants oraux non-AVK."
      },
      {
       "value": "IV",
       "label": "La Commission considère que les spécialités ELIQUIS apportent une amélioration du service médical rendu mineure (ASMR IV) par rapport à la warfarine dans la prévention de l’accident vasculaire cérébral et de l’embolie systémique chez les patients adultes atteints de fibrillation atriale non valvulaire et présentant un ou plusieurs facteurs de risque.\nLes nouvelles données disponibles ne sont pas susceptibles de modifier l’appréciation précédente de la Commission, qui considère que les spécialités ELIQUIS apportent une amélioration du service médical rendu mineure (ASMR IV) en termes d’efficacité par rapport à l’énoxaparine pour la prévention des événements thromboemboliques veineux chez les patients adultes bénéficiant d’une intervention chirurgicale programmée pour prothèse totale de hanche ou de genou."
      }
     ]
    },
    {
     "dossier": "CT-13901",
     "date": "2015-04-01",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_2038860",
     "products": [
      "ELIQUIS"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "ELIQUIS n’apporte pas d’amélioration du service médicale rendu (ASMR V) dans le traitement de la thrombose veineuse profonde (TVP) et de l’embolie pulmonaire (EP), et prévention de la récidive de TVP et d’EP chez l’adulte."
      }
     ]
    },
    {
     "dossier": "CT-13857",
     "date": "2014-12-17",
     "motif": "Réévaluation SMR",
     "url": "https://www.has-sante.fr/jcms/c_2008303",
     "products": [
      "ELIQUIS"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "IV",
       "label": "La Commission considère que les spécialités ELIQUIS 2,5 mg, comprimés pelliculés et ELIQUIS 5 mg, comprimés pelliculés apportent une amélioration du service médical rendu mineure (ASMR IV) dans la stratégie thérapeutique de la prévention de l’accident vasculaire cérébral (AVC) et de l’embolie systémique chez les patients adultes atteints de fibrillation atriale non valvulaire (FANV) et présentant un ou plusieurs facteur(s) de risque tels que :\n• antécédent d’AVC ou d’accident ischémique transitoire (AIT),\n• âge = 75 ans\n• hypertension artérielle\n• diabète,\n• insuffisance cardiaque symptomatique (classe NYHA = II)."
      }
     ]
    },
    {
     "dossier": "CT-12671",
     "date": "2013-06-12",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_1616483",
     "products": [
      "ELIQUIS"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "ELIQUIS n’apporte pas d’amélioration du service médical rendu (ASMR V, inexistante) en prévention de l’accident vasculaire cérébral (AVC) et de l’embolie systémique (ES) chez les patients adultes atteints de fibrillation atriale non valvulaire (FANV) et ayant un ou plusieurs facteur(s) de risque tels que : antécédent d’AVC ou d’accident ischémique transitoire (AIT) . âge = 75 ans . hypertension artérielle . diabète . insuffisance cardiaque symptomatique (classe NYHA = II). Les patients qui seraient les plus susceptibles de bénéficier de l’apixaban, comme du rivaroxaban et du dabigatran, sont ceux chez lesquels le contrôle de l’INR n’est pas obtenu sous AVK. Ces patients requièrent une surveillance clinique étroite alors que l’absence de nécessité de mesurer le degré d’anticoagulation peut conduire à espacer les consultations de suivi . le suivi étroit en pratique courante ne doit pas être oublié. Les données cliniques de l’apixaban chez les patients âgés (> 75 ans), insuffisants rénaux ou de faible poids corporel, qui sont à risque de saignements, sont actuellement limitées. De plus, les comparaisons indirectes, faites à partir des trois études RELY, ROCKET AF et ARISTOTLE dont la méthodologie et les caractéristiques des patients inclus diffèrent, ne permettent pas de hiérarchiser ces trois médicaments."
      }
     ]
    },
    {
     "dossier": "CT-12670",
     "date": "2013-06-12",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_1616483",
     "products": [
      "ELIQUIS"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "ELIQUIS n’apporte pas d’amélioration du service médical rendu (ASMR V, inexistante) en prévention de l’accident vasculaire cérébral (AVC) et de l’embolie systémique (ES) chez les patients adultes atteints de fibrillation atriale non valvulaire (FANV) et ayant un ou plusieurs facteur(s) de risque tels que : antécédent d’AVC ou d’accident ischémique transitoire (AIT) . âge = 75 ans . hypertension artérielle . diabète . insuffisance cardiaque symptomatique (classe NYHA = II). Les patients qui seraient les plus susceptibles de bénéficier de l’apixaban, comme du rivaroxaban et du dabigatran, sont ceux chez lesquels le contrôle de l’INR n’est pas obtenu sous AVK. Ces patients requièrent une surveillance clinique étroite alors que l’absence de nécessité de mesurer le degré d’anticoagulation peut conduire à espacer les consultations de suivi . le suivi étroit en pratique courante ne doit pas être oublié. Les données cliniques de l’apixaban chez les patients âgés (> 75 ans), insuffisants rénaux ou de faible poids corporel, qui sont à risque de saignements, sont actuellement limitées. De plus, les comparaisons indirectes, faites à partir des trois études RELY, ROCKET AF et ARISTOTLE dont la méthodologie et les caractéristiques des patients inclus diffèrent, ne permettent pas de hiérarchiser ces trois médicaments."
      }
     ]
    },
    {
     "dossier": "CT-11097",
     "date": "2012-01-18",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_1215842",
     "products": [
      "ELIQUIS"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "IV",
       "label": "ELIQUIS apporte une amélioration du service médical rendu de niveau IV (ASMR mineure) par rapport à l'énoxaparine en termes d'efficacité pour la thromboprophylaxie après la pose d'une prothèse totale de genou ou de hanche."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [
     {
      "name": "Apixaban Accord",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/apixaban-accord",
      "status": "Authorised",
      "kind": "generic"
     },
     {
      "name": "Eliquis",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/eliquis",
      "status": "Authorised",
      "kind": "reference"
     }
    ],
    "FR": [
     {
      "name": "ELIQUIS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62111096/extrait",
      "products": 6
     }
    ],
    "ES": [
     {
      "name": "ELIQUIS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/11691003IP/FT_11691003IP.html",
      "products": 4,
      "atc": [
       "B01AF02"
      ]
     }
    ],
    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  },
  "levetiracetam": {
   "atc": "N03AX14",
   "epar": [
    {
     "name": "Keppra",
     "number": "EMEA/H/C/000277",
     "status": "Authorised",
     "inn": "levetiracetam",
     "substance": "levetiracetam",
     "atc": [
      "N03AX14"
     ],
     "holder": "UCB Pharma SA",
     "generic": false,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2000-09-29",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-04-01",
     "therapeutic_area": "Epilepsy",
     "indication": "Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Keppra is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/keppra"
    },
    {
     "name": "Levetiracetam Accord",
     "number": "EMEA/H/C/002290",
     "status": "Authorised",
     "inn": "levetiracetam",
     "substance": "levetiracetam",
     "atc": [
      "N03AX14"
     ],
     "holder": "Accord Healthcare S.L.U.",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2011-10-03",
     "refused": null,
     "withdrawn": null,
     "updated": "2025-12-09",
     "therapeutic_area": "Epilepsy",
     "indication": "Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-accord"
    },
    {
     "name": "Levetiracetam Actavis",
     "number": "EMEA/H/C/002355",
     "status": "Authorised",
     "inn": "levetiracetam",
     "substance": "levetiracetam",
     "atc": [
      "N03AX14"
     ],
     "holder": "Actavis Group PTC ehf",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2011-10-03",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-01-26",
     "therapeutic_area": "Epilepsy",
     "indication": "Levetiracetam Actavis is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Actavis is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-actavis"
    },
    {
     "name": "Levetiracetam Actavis Group",
     "number": "EMEA/H/C/002305",
     "status": "Authorised",
     "inn": "levetiracetam",
     "substance": "levetiracetam",
     "atc": [
      "N03AX14"
     ],
     "holder": "Actavis Group PTC ehf",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2011-12-04",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-01-26",
     "therapeutic_area": "Epilepsy",
     "indication": "Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Actavis Group is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-actavis-group"
    },
    {
     "name": "Levetiracetam Hospira",
     "number": "EMEA/H/C/002783",
     "status": "Authorised",
     "inn": "levetiracetam",
     "substance": "levetiracetam",
     "atc": [
      "N03AX14"
     ],
     "holder": "Pfizer Europe MA EEIG",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2014-01-07",
     "refused": null,
     "withdrawn": null,
     "updated": "2025-12-15",
     "therapeutic_area": "Epilepsy",
     "indication": "Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Hospira is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-hospira"
    },
    {
     "name": "Levetiracetam ratiopharm",
     "number": "EMEA/H/C/002244",
     "status": "Authorised",
     "inn": "levetiracetam",
     "substance": "levetiracetam",
     "atc": [
      "N03AX14"
     ],
     "holder": "ratiopharm GmbH",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2011-08-26",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-01-26",
     "therapeutic_area": "Epilepsy",
     "indication": "Levetiracetam ratiopharm is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam ratiopharm is indicated as adjunctive therapy: in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-ratiopharm"
    },
    {
     "name": "Levetiracetam Sun",
     "number": "EMEA/H/C/002051",
     "status": "Authorised",
     "inn": "levetiracetam",
     "substance": "levetiracetam",
     "atc": [
      "N03AX14"
     ],
     "holder": "Sun Pharmaceutical Industries Europe B.V.",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2011-12-14",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-01-05",
     "therapeutic_area": "Epilepsy",
     "indication": "Levetiracetam Sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Sun is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. Levetiracetam Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-sun"
    },
    {
     "name": "Levetiracetam Teva",
     "number": "EMEA/H/C/002316",
     "status": "Authorised",
     "inn": "levetiracetam",
     "substance": "levetiracetam",
     "atc": [
      "N03AX14"
     ],
     "holder": "Teva B.V.",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2011-08-25",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-01-26",
     "therapeutic_area": "Epilepsy",
     "indication": "Levetiracetam Teva is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Teva is indicated as adjunctive therapy: in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-teva"
    },
    {
     "name": "Matever",
     "number": "EMEA/H/C/002024",
     "status": "Authorised",
     "inn": "levetiracetam",
     "substance": "levetiracetam",
     "atc": [
      "N03AX14"
     ],
     "holder": "Pharmathen S.A.",
     "generic": true,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2011-10-03",
     "refused": null,
     "withdrawn": null,
     "updated": "2025-12-16",
     "therapeutic_area": "Epilepsy",
     "indication": "Matever is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Matever is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/matever"
    },
    {
     "name": "Epixram",
     "number": "EMEA/H/C/006186",
     "status": "Application withdrawn",
     "inn": "levetiracetam",
     "substance": null,
     "atc": [
      "N03AX14"
     ],
     "holder": "Neuraxpharm Pharmaceuticals S.L.",
     "generic": false,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": null,
     "refused": null,
     "withdrawn": null,
     "updated": "2025-01-09",
     "therapeutic_area": "Epilepsy;Epilepsy, Generalized;Myoclonic Epilepsy, Juvenile",
     "indication": "Treatment of partial onset seizures.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/epixram"
    }
   ],
   "has_ct": [
    {
     "dossier": "CT-21259",
     "date": "2025-07-16",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3638197",
     "products": [
      "KEPPRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par KEPPRA (lévétiracétam) 100 mg/mL, solution buvable en flacon de 150 mL avec seringue graduée de 5 mL, est important en association dans le traitement des crises partielles avec ou sans généralisation secondaire uniquement chez le nourrisson et le jeune enfant à partir de 6 mois à moins de 4 ans présentant une épilepsie."
      },
      {
       "value": "Insuffisant",
       "label": "Le service médical rendu par KEPPRA (lévétiracétam) 100 mg/mL, solution buvable en flacon de 150 mL avec seringue graduée de 5 mL, est insuffisant pour justifier d’une prise en charge par la solidarité nationale dans les autres situations cliniques couvertes par l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-19212",
     "date": "2021-06-02",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3271864",
     "products": [
      "LEPTAX"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEPTAX 750 mg, comprimé pelliculé sécable (lévétiracétam) est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un générique qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux spécialités à base de lévétiracétam déjà disponibles."
      }
     ]
    },
    {
     "dossier": "CT-18271",
     "date": "2020-01-08",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3146430",
     "products": [
      "LEVETIRACETAM TILLOMED"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVETIRACETAM TILLOMED 100 mg/ml, solution à diluer pour perfusion, est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un générique qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport au princeps KEPPRA 100 mg/ml, solution à diluer pour perfusion (lévétiracétam)."
      }
     ]
    },
    {
     "dossier": "CT-17076",
     "date": "2018-07-11",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2865439",
     "products": [
      "LEVETIRACETAM ARROW LAB"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVETIRACETAM ARROW LAB 100 mg/mL, solution à diluer pour perfusion est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport au princeps KEPPRA 100 mg/ml, solution à diluer pour perfusion déjà inscrit."
      }
     ]
    },
    {
     "dossier": "CT-16677",
     "date": "2018-01-24",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2824482",
     "products": [
      "LEVETIRACETAM HIKMA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVETIRACETAM HIKMA est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un générique qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la spécialité princeps KEPPRA 100 mg/ml solution à diluer pour perfusion déjà inscrite."
      }
     ]
    },
    {
     "dossier": "CT-16494",
     "date": "2017-10-25",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2804103",
     "products": [
      "LEVETIRACETAM STRAGEN"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVETIRACETAM STRAGEN est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un médicament hybride qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la spécialité de référence KEPPRA 100 mg/ml solution à diluer pour perfusion déjà inscrite."
      }
     ]
    },
    {
     "dossier": "CT-14902",
     "date": "2016-04-20",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2630031",
     "products": [
      "LEVETIRACETAM ARROW LAB"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVETIRACETAM ARROW LAB 500 mg, comprimé pelliculé sécable est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à la présentation déjà inscrite."
      }
     ]
    },
    {
     "dossier": "CT-14432",
     "date": "2015-07-01",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2048970",
     "products": [
      "KEPPRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités KEPPRA est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Ces spécialités sont des compléments de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-14046",
     "date": "2015-04-01",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2030395",
     "products": [
      "LEVIDCEN"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités LEVIDCEN, granulés enrobés est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Les spécialités LEVIDCEN, granulés enrobés n’apportent pas d’amélioration du service médical rendu (ASMR V) par rapport aux spécialités à base de lévétiracétam déjà disponibles."
      }
     ]
    },
    {
     "dossier": "CT-13590",
     "date": "2014-04-23",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_1740075",
     "products": [
      "LEVETIRACETAM HOSPIRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LEVETIRACETAM HOSPIRA 100 mg/ml est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d’amélioration du service médical rendu (ASMR V, inexistante) par rapport aux autres spécialités à base de lévétiracétam déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-12792",
     "date": "2013-04-17",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_1638075",
     "products": [
      "KEPPRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par les spécialités KEPPRA reste important dans les indications de l’AMM."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-12789",
     "date": "2013-04-17",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "KEPPRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par KEPPRA est important dans les indications de l'AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d'amélioration du service médical rendu (ASMR V, inexistante) par rapport aux autres présentations de KEPPRA."
      }
     ]
    },
    {
     "dossier": "CT-12538",
     "date": "2012-11-21",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "LEVETIRACETAM ARROW"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "La Commission considère que le service médical rendu par LEVETIRACETAM ARROW 100mg/ml, solution à diluer pour perfusion est important dans les indications de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d’amélioration du service médical rendu (ASMR V) par rapport à KEPPRA 100 mg/ml, solution à diluer pour perfusion."
      }
     ]
    },
    {
     "dossier": "CT-12013",
     "date": "2012-02-29",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "LEVETIRACETAM SUN"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par cette spécialité est important dans les indications de l'AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d'amélioration du service médical rendu (ASMR V) par rapport à KEPPRA 100 mg/ml, solution à diluer pour perfusion."
      }
     ]
    },
    {
     "dossier": "CT-11788",
     "date": "2012-01-04",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "LEVETIRACETAM VIATRIS"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par cette spécialité est important dans les indications de l'AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Absence d'amélioration du service médical rendu (ASMR V) par rapport à KEPPRA 100 mg/ml, solution à diluer pour perfusion."
      }
     ]
    },
    {
     "dossier": "CT-8027",
     "date": "2010-06-16",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_969537",
     "products": [
      "KEPPRA"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "III",
       "label": "Dans un contexte d'insuffisance d'évaluation des antiépileptiques utilisés chez l'enfant et de formes galéniques adaptées de ces antiépileptiques, Keppra 100 mg/ml solution buvable avec seringues de 1 ml et 3 ml apporte une amélioration du service médical rendu modéré (ASMR III) en association dans le traitement des crises partielles avec ou sans généralisation secondaire chez le nourrisson à partir de 1 mois et chez l'enfant de moins de 4 ans, au même titre que Keppra 100 mg/ml solution buvable avec seringue de 10 ml chez l'enfant âgé de plus de 4 ans dans cette indication."
      }
     ]
    },
    {
     "dossier": "CT-4471",
     "date": "2007-10-10",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_603015",
     "products": [
      "KEPPRA"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "IV",
       "label": "Compte tenu de son rapport efficacité/effets indésirables, KEPPRA, utilisé en association dans la prise en charge des crises généralisées tonico-cloniques primaires chez les patients atteints d'épilepsie généralisée idiopathique, apporte une amélioration du service médical rendu de niveau IV."
      }
     ]
    },
    {
     "dossier": "CT-3913",
     "date": "2007-02-28",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_496162",
     "products": [
      "KEPPRA"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "III",
       "label": "Le lévétiracetam apporte une amélioration du service médical rendu modérée (ASMR III) dans la prise en charge de l'adulte et de l'enfant de plus de 12 ans présentant une épilepsie myoclonique juvénile."
      },
      {
       "value": "IV",
       "label": "Le lévétiracetam apporte une amélioration du service médical rendu mineure (ASMR IV) en termes de tolérance par rapport à la carbamazépine LP en monothérapie dans le traitement des crises partielles avec ou sans généralisation secondaire chez les patients à partir de 16 ans présentant une épilepsie nouvellement diagnostiquée."
      }
     ]
    },
    {
     "dossier": "CT-2943",
     "date": "2006-07-19",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_460095",
     "products": [
      "KEPPRA"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le niveau de service médical rendu pour ces spécialités est important dans les indications de l'AMM."
      }
     ],
     "asmr": [
      {
       "value": "IV",
       "label": "Compte tenu de l'absence de formulations injectables d'antiépileptiques de 3ème génération, KEPPRA 100 mg/ml solution à diluer pour perfusion apporte une amélioration du service médical rendu de niveau IV dans l'indication."
      }
     ]
    },
    {
     "dossier": "CT-2838",
     "date": "2006-07-19",
     "motif": "Extension d'indication",
     "url": null,
     "products": [
      "KEPPRA"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "III",
       "label": "Compte tenu du faible risque d'interactions pharmacocinétiques du lévitiracétam et de la carence galénique des antiépileptiques de 3ème génération utilisés chez l'enfant, KEPPRA administré par voie orale apporte une amélioration du service médical rendu de niveau III dans l'extension d'indication."
      }
     ]
    },
    {
     "dossier": "CT-2837",
     "date": "2006-07-19",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "KEPPRA"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "KEPPRA 100 mg/ml solution buvable, complément de gamme de KEPPRA 250 mg, 500 mg et 100 mg, comprimés pelliculés, n'apporte pas d'amélioration du service médical rendu (niveau V) chez l'adulte."
      },
      {
       "value": "III",
       "label": "Compte tenu du faible risque d'interactions pharmacocinétiques du lévitiracétam et de la carence galénique des antiépileptiques de 3ème génération utilisés chez l'enfant, KEPPRA administré par voie orale apporte une amélioration du service médical rendu de niveau III dans l'extension d'indication."
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    }
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      "name": "Levetiracetam Accord",
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      "products": 3
     },
     {
      "name": "LEVETIRACETAM CRISTERS",
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     {
      "name": "LEVETIRACETAM KRKA",
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     {
      "name": "LEVETIRACETAM SANDOZ",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64422384/extrait",
      "products": 4
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     {
      "name": "LEVETIRACETAM SUN",
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      "products": 1
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     {
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      "name": "LEVETIRACETAM TILLOMED",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/66707204/extrait",
      "products": 1
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     {
      "name": "LEVETIRACETAM VIATRIS",
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     },
     {
      "name": "LEVETIRACETAM ZENTIVA",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65333230/extrait",
      "products": 3
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     {
      "name": "LEVETIRACETAM ZYDUS",
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      "products": 3
     },
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      "name": "LEVIDCEN",
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      "atc": [
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     },
     {
      "name": "LEVETIRACETAM ALMUS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/76131/FT_76131.html",
      "products": 2,
      "atc": [
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     },
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      "atc": [
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     },
     {
      "name": "LEVETIRACETAM ARISTO",
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      "atc": [
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     },
     {
      "name": "LEVETIRACETAM AUROVITAS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/81481/FT_81481.html",
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      "atc": [
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     },
     {
      "name": "LEVETIRACETAM CINFA",
      "url": "https://cima.aemps.es/cima/dochtml/ft/76440/FT_76440.html",
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      "atc": [
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     },
     {
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      "atc": [
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     },
     {
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      "atc": [
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     },
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     {
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     },
     {
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     {
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     {
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     },
     {
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     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2000-06-09",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-03-05",
     "therapeutic_area": "Diabetes Mellitus",
     "indication": "Treatment of diabetes mellitus in adults, adolescents and children aged two years and above",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lantus"
    },
    {
     "name": "Ondibta",
     "number": "EMEA/H/C/006136",
     "status": "Authorised",
     "inn": "insulin glargine",
     "substance": "insulin glargine",
     "atc": [
      "A10AE04"
     ],
     "holder": "Sandoz GmbH",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": true,
     "conditional": false,
     "authorised": "2026-01-09",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-08-21",
     "therapeutic_area": "Diabetes Mellitus",
     "indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ondibta"
    },
    {
     "name": "Semglee",
     "number": "EMEA/H/C/004280",
     "status": "Authorised",
     "inn": "insulin glargine",
     "substance": "insulin glargine",
     "atc": [
      "A10AE04"
     ],
     "holder": "Biosimilar Collaborations Ireland Limited",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2018-03-23",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-06-19",
     "therapeutic_area": "Diabetes Mellitus",
     "indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/semglee"
    },
    {
     "name": "Toujeo (previously Optisulin)",
     "number": "EMEA/H/C/000309",
     "status": "Authorised",
     "inn": "insulin glargine",
     "substance": "insulin glargine",
     "atc": [
      "A10AE04"
     ],
     "holder": "Sanofi-aventis Deutschland GmbH",
     "generic": false,
     "biosimilar": false,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2000-06-26",
     "refused": null,
     "withdrawn": null,
     "updated": "2026-03-05",
     "therapeutic_area": "Diabetes Mellitus",
     "indication": "Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/toujeo"
    },
    {
     "name": "Lusduna",
     "number": "EMEA/H/C/004101",
     "status": "Withdrawn",
     "inn": "insulin glargine",
     "substance": "insulin glargine",
     "atc": [
      "A10AE04"
     ],
     "holder": "Merck Sharp & Dohme B.V.",
     "generic": false,
     "biosimilar": true,
     "orphan": false,
     "additional_monitoring": false,
     "conditional": false,
     "authorised": "2017-01-03",
     "refused": null,
     "withdrawn": "2018-10-29",
     "updated": "2019-01-22",
     "therapeutic_area": "Diabetes Mellitus",
     "indication": "Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.",
     "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lusduna"
    }
   ],
   "has_ct": [
    {
     "dossier": "CT-18415",
     "date": "2020-06-10",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/p_3194972",
     "products": [
      "TOUJEO"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "La Commission considère que le service médical rendu par TOUJEO (insuline glargine) est important dans le traitement du diabète sucré de l’adolescent et de l’enfant à partir de 6 ans."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Compte tenu :\n• de la démonstration de la non-infériorité de TOUJEO (insuline glargine) par rapport à LANTUS (insuline glargine), dans une étude ouverte, chez des enfants âgés de plus de 6 ans et des adolescent atteints de diabète de type 1 en termes de variation d’HbA1c après 26 semaines de traitement, avec une marge de non-infériorité prédéfinie de 0,3% (critère de jugement principal),\n• de la seule disponibilité de résultats d’efficacité sur un critère intermédiaire et de l’absence de donnée de morbi-mortalité,\n• du profil de tolérance de TOUJEO (insuline glargine) qui apparait similaire à celui de LANTUS (insuline glargine) dans cette même étude,\n• et de l’absence de donnée de qualité de vie,\nla Commission de la Transparence considère que TOUJEO (insuline glargine) n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à LANTUS (insuline glargine) dans la prise en charge du diabète sucré chez l’enfant à partir de 6 ans et l’adolescent"
      }
     ]
    },
    {
     "dossier": "CT-17811",
     "date": "2019-06-12",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/p_3098014",
     "products": [
      "TOUJEO"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par TOUJEO 300 unités/ml en stylo prérempli DoubleStar de 3 ml de solution injectable est important dans l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette présentation est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-16883",
     "date": "2018-04-18",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2848651",
     "products": [
      "LANTUS",
      "LANTUS SOLOSTAR",
      "TOUJEO"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par LANTUS reste important dans le traitement du diabète sucré de l’adulte, de l’adolescent et de l’enfant à partir de 2 ans."
      },
      {
       "value": "Important",
       "label": "Le service médical rendu par TOUJEO reste important dans le traitement du diabète sucré de l’adulte."
      }
     ],
     "asmr": []
    },
    {
     "dossier": "CT-15153",
     "date": "2016-05-25",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2635031",
     "products": [
      "ABASAGLAR"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par ABASAGLAR 100 unités/ml, solution injectable en stylo prérempli jetable est important dans l’indication de l’AMM."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations déjà inscrites."
      }
     ]
    },
    {
     "dossier": "CT-14452",
     "date": "2015-10-07",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2569089",
     "products": [
      "TOUJEO"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Compte tenu des données disponibles, à savoir des études de non infériorité versus LANTUS, et de son profil de tolérance, TOUJEO 300 UI/ml n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à LANTUS 100 UI/ml."
      }
     ]
    },
    {
     "dossier": "CT-14408",
     "date": "2015-09-23",
     "motif": "Inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_2569216",
     "products": [
      "ABASAGLAR"
     ],
     "smr": [
      {
       "value": "Important",
       "label": "Le service médical rendu par ABASAGLAR est important dans le traitement du diabète sucré de l’adulte, de l’adolescent et de l’enfant à partir de 2 ans."
      }
     ],
     "asmr": [
      {
       "value": "V",
       "label": "En tant que médicament biosimilaire de la spécialité LANTUS, ABASAGLAR n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la prise en charge du diabète sucré de l’adulte, de l’adolescent et de l’enfant à partir de 2 ans."
      }
     ]
    },
    {
     "dossier": "CT-12976",
     "date": "2014-05-07",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_1749754",
     "products": [
      "LANTUS",
      "LANTUS SOLOSTAR"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Compte tenu, d’une part du contrôle glycémique obtenu avec LANTUS (insuline glargine) comparable à celui observé avec l’insuline NPH et l’insuline détémir (LEVEMIR), de l’absence de différence entre les insulines glargine, détémir et NPH en termes de survenue d’hypoglycémies sévères et entre les insulines glargine et détémir sur les hypoglycémies globales et nocturnes, des avis d’experts qui ne reconnaissent pas un avantage dans leur pratique quotidienne à l’utilisation de LANTUS par rapport à un autre analogue lent de l’insuline, et, d’autre part, des recommandations actuelles qui ne privilégient plus l’intensification du traitement du diabète de type 2 ce qui réduit en conséquence la survenue d’hypoglycémies, la Commission de la transparence ne peut confirmer l’avantage reconnu auparavant à LANTUS (ASMR mineure en termes de tolérance) dans le diabète de type 1 et de type 2. Ainsi, la Commission considère que LANTUS (insuline glargine) n’apporte pas d’amélioration du service médical rendu (ASMR V, inexistante) dans la prise en charge des patients adultes ou adolescents et des enfants âgés de plus de 2 ans atteints de diabète de type 1 ou de type 2."
      }
     ]
    },
    {
     "dossier": "CT-13451",
     "date": "2013-12-18",
     "motif": "Extension d'indication",
     "url": "https://www.has-sante.fr/jcms/c_1722903",
     "products": [
      "LANTUS",
      "LANTUS SOLOSTAR"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "LANTUS n’apporte pas d’amélioration du service médical rendu (ASMR V, inexistante) dans la prise en charge des enfants âgés de 2 à 5 ans atteints de diabète de type 1."
      }
     ]
    },
    {
     "dossier": "CT-9433",
     "date": "2011-05-25",
     "motif": "Réévaluation SMR et ASMR",
     "url": "https://www.has-sante.fr/jcms/c_1062696",
     "products": [
      "LANTUS",
      "LANTUS SOLOSTAR"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "La Commission considère, dans l'état actuel du dossier, que l'insuline glargine n'apporte pas d'amélioration du service médical rendu (niveau V) par rapport aux autres insulines."
      }
     ]
    },
    {
     "dossier": "CT-5385",
     "date": "2009-01-21",
     "motif": "Renouvellement d'inscription (CT)",
     "url": "https://www.has-sante.fr/jcms/c_748385",
     "products": [
      "LANTUS"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "IV",
       "label": "Compte tenu des résultats des études cliniques disponibles et de l'étude observationnelle réalisée qui a confirmé l'apport de LANTUS en conditions réelles d'utilisation, la Commission considère que LANTUS apporte une amélioration du service médical rendu de niveau IV (mineure) en termes de tolérance."
      }
     ]
    },
    {
     "dossier": "CT-3837",
     "date": "2006-11-27",
     "motif": "Inscription (CT)",
     "url": null,
     "products": [
      "LANTUS SOLOSTAR"
     ],
     "smr": [],
     "asmr": [
      {
       "value": "V",
       "label": "Cette spécialité est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu."
      }
     ]
    }
   ],
   "trade_names": {
    "EU": [
     {
      "name": "Abasaglar (previously Abasria)",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/abasaglar",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Lantus",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lantus",
      "status": "Authorised",
      "kind": "reference"
     },
     {
      "name": "Ondibta",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ondibta",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Semglee",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/semglee",
      "status": "Authorised",
      "kind": "biosimilar"
     },
     {
      "name": "Toujeo (previously Optisulin)",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/toujeo",
      "status": "Authorised",
      "kind": "reference"
     },
     {
      "name": "Lusduna",
      "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lusduna",
      "status": "Withdrawn",
      "kind": "biosimilar"
     }
    ],
    "FR": [
     {
      "name": "ABASAGLAR",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64332894/extrait",
      "products": 1
     },
     {
      "name": "LANTUS",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/64745003/extrait",
      "products": 2
     },
     {
      "name": "LANTUS SOLOSTAR",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65979151/extrait",
      "products": 1
     },
     {
      "name": "SEMGLEE",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60408661/extrait",
      "products": 1
     },
     {
      "name": "TOUJEO",
      "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62030744/extrait",
      "products": 2
     }
    ],
    "ES": [
     {
      "name": "ABASAGLAR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/114944012/FT_114944012.html",
      "products": 1,
      "atc": [
       "A10AE04"
      ]
     },
     {
      "name": "LANTUS",
      "url": "https://cima.aemps.es/cima/dochtml/ft/00134006/FT_00134006.html",
      "products": 2,
      "atc": [
       "A10AE04"
      ]
     },
     {
      "name": "LANTUS SOLOSTAR",
      "url": "https://cima.aemps.es/cima/dochtml/ft/00134033/FT_00134033.html",
      "products": 1,
      "atc": [
       "A10AE04"
      ]
     },
     {
      "name": "SEMGLEE",
      "url": "https://cima.aemps.es/cima/dochtml/ft/1181270003IP/FT_1181270003IP.html",
      "products": 2,
      "atc": [
       "A10AE04"
      ]
     },
     {
      "name": "TOUJEO",
      "url": "https://cima.aemps.es/cima/dochtml/ft/1000133038/FT_1000133038.html",
      "products": 2,
      "atc": [
       "A10AE04"
      ]
     }
    ],
    "UK": [],
    "IT": [],
    "US": [],
    "US_discontinued": [],
    "CA": []
   },
   "trade_names_source": {
    "EU": "ema",
    "FR": "fr-bdpm",
    "ES": "es-nomenclator",
    "UK": "uk-dmd",
    "IT": "dysnet-teratogens",
    "US": "dysnet-teratogens",
    "US_discontinued": "dysnet-teratogens",
    "CA": "dysnet-teratogens"
   },
   "register": null,
   "register_name": null
  }
 }
}