Mycophenolate mofetil Pregnancy: see this medicine in the DysNet teratogen register

European Union, central authorisation (4)

CellCept, Myclausen, Mycophenolate mofetil Teva, Myfenax [5]

France (8)

CELLCEPT, MYCOPHENOLATE MOFETIL ARROW, MYCOPHENOLATE MOFETIL BIOGARAN, MYCOPHENOLATE MOFETIL SANDOZ, MYCOPHENOLATE MOFETIL VIATRIS, MYFENAX, MYFORTIC, MYCOPHENOLATE MOFETIL TEVA* [6] [7]

Spain (18)

ACIDO MICOFENOLICO STADA, CELLCEPT, CEPTAVA, MICOFENOLATO DE MOFETIL STADA, 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 TECNIGEN, MICOFENOLATO MOFETILO ACTAVIS, MICOFENOLATO MOFETILO NORMON, MYFENAX, MYFORTIC, MICOFENOLATO DE MOFETILO STADA*, MICOFENOLATO DE MOFETILO TILLOMED*, MICOFENOLATO MOFETILO TEVA* [8] [7]

Italy (13)

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 [7]

United States (3)

Cellcept, Myfortic, Myhibbin [7]

Canada (14)

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 [7]

In other languages

acide mycophenolique, mycophénolate mofétil (French); Mycophenolat-Mofetil, Mycophenolsäure (German); acido micofenolico (Spanish); acido micofenolico, Micofenolato mofetile (Italian); mycofenolzuur (Dutch); mofetil micofenolato, Ácido micofenólico (Portuguese); acidum mycophenolicum (Latin) [7]

Links lead to the official product page: the EPAR for the European Union, the public medicines database for France, the CIMA summary of product characteristics for Spain, the dm+d for the United Kingdom. An asterisk marks a name taken from the DysNet register only.

• CellCept · authorised · reference medicine · Roche Registration GmbH · authorised 14 February 1996
  Indication (EMA text)

  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.

• Myclausen · authorised · generic · Passauer Pharma GmbH · authorised 7 October 2010
  Indication (EMA text)

  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.

• Mycophenolate mofetil Teva · authorised · generic · Teva Pharma B.V. · authorised 21 February 2008
  Indication (EMA text)

  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.

• Myfenax · authorised · generic · Teva B.V. · authorised 21 February 2008
  Indication (EMA text)

  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.

European Medicines Agency list of 09/10/2026 - 18:00 [5].

PubMed counts 11,125 papers on this medicine [9]. The selection gives the most recent of each type; the Method page says how it is made. See the search in PubMed ↗

Cochrane reviews (24)

• Larkins NG, et al. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024. PubMed 39513526 ↗ doi ↗
• Alladin A, et al. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024. PubMed 38864363 ↗ doi ↗
• Edwards Mayhew RG, et al. Non-biologic, steroid-sparing therapies for non-infectious intermediate, posterior, and panuveitis in adults. Cochrane Database Syst Rev. 2022. PubMed 36315029 ↗ doi ↗
• Azukaitis K, et al. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022. PubMed 35230699 ↗ doi ↗
• Hodson EM, et al. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022. PubMed 35224732 ↗ doi ↗

All 24 results in PubMed ↗

INN

mycophenolic acid source ↗

CAS

128794-94-5

ATC

L04AA06 (systemic)

SNOMED CT

386976000, 409330005, 409331009, 441632007

RxNorm

68149 ↗, 7145 ↗

Wikidata

Q420553 ↗, Q4567614 ↗

Names and identifiers taken from the DysNet register [7].

SMR: actual clinical benefit. ASMR: improvement in actual clinical benefit, from I (major) to V (none). Opinions taken from the BDPM [6].

• CT-21391 · 19 November 2025 · Extension d'indication · SMR Important · ASMR IV · CELLCEPT
  Wording of the opinion, in French

  SMR : 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 : 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).

• CT-17036 · 4 September 2019 · Renouvellement d'inscription (CT) · SMR Important · CELLCEPT
  Wording of the opinion, in French

  SMR : Le service médical rendu par CELLCEPT reste important dans les indications de l’AMM.

• CT-13925 · 22 June 2016 · Renouvellement d'inscription (CT) · SMR Important · MYFORTIC
  Wording of the opinion, in French

  SMR : 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 ».

• CT-432 · 28 January 2004 · Inscription (CT) · ASMR V · MYFORTIC
  Wording of the opinion, in French

  ASMR : 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).

• TA481 · Immunosuppressive therapy for kidney transplant in adults · 11 October 2017 · published
• TA482 · Immunosuppressive therapy for kidney transplant in children and young people · 11 October 2017 · published
• NICE list [10]

• SMC 144/04 · 10 January 2005 · Mycophenolate sodium (Myfortic®) · accepted · Full
  Indication

  In combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants

• SMC advice [11]

The G-BA has run no early benefit assessment (AMNOG) of this medicine on its own [12].

The AEMPS database of therapeutic positioning reports holds no report on this medicine [13].