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mycophenolate mofetil

CellCept · ATC code L04AA06

Also known as: Mycophenolatmofetil · Brand names: CellCept, Mowel, Mycophenolat Mofetil Sandoz, Mycophenolatmofetil Accord, Mycophenolat, Mycophenolatmofetil Al, Mycophenolatmofetil Ascend, Mycophenolatmofetil Biomo, Mycophenolatmofetil Hexal, Mycophenolatmofetil Tillomed, Celptu, Micosef, Mikocept, Mikotu, Mofecept …

Key facts
Active substance
mycophenolate mofetil
Drug class
Immunosuppressive drug
ATC code
L04AA06
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
CellCept 250 mg hard capsules · CellCept 500 mg powder for concentrate for solution for infusion · CellCept 1 g/5 ml powder for oral suspension · CellCept 500 mg film-coated tablets
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-27

Key facts

Mycophenolate mofetil (CellCept) is an immunosuppressant whose active metabolite is mycophenolic acid. It is used with ciclosporin and corticosteroids to prevent acute rejection after organ transplantation.

What it is used for

  • Capsules, tablets, suspension: prophylaxis of acute rejection after allogeneic renal, cardiac or hepatic transplant in adults and children (1 to 18 years)
  • Infusion: prophylaxis of acute rejection after renal or hepatic transplant in adults
  • In each case combined with ciclosporin and corticosteroids

Dosing

  • Renal transplant (adults, oral): 1 g twice daily (2 g daily dose), started within 72 hours
  • Cardiac transplant (adults, oral): 1.5 g twice daily (3 g daily dose), started within 5 days
  • Hepatic transplant: intravenous 1 g twice daily for the first 4 days, then oral 1.5 g twice daily
  • Children (oral): initial 600 mg/m2 twice daily (not exceeding 2 g daily); may increase to 900 mg/m2 in cardiac and hepatic transplant
  • Infusion: not by rapid or bolus injection; may be given for up to 14 days
  • Severe chronic renal impairment after renal transplant: avoid doses above 1 g twice daily outside the immediate post-transplant period

Contraindications

  • Hypersensitivity to mycophenolate mofetil, mycophenolic acid or excipients (infusion also: polysorbate 80)
  • Women of childbearing potential not using highly effective contraception or without a pregnancy test before starting
  • Pregnancy, unless there is no suitable alternative to prevent rejection
  • Breastfeeding

Important warnings

  • Increased risk of lymphomas and other malignancies, particularly of the skin; limit sun and UV exposure
  • Increased susceptibility to infections
  • Different oral formulations should not be substituted without clinical supervision

Side effects

  • Among the most common and/or serious: diarrhoea (up to 52.6%), leukopenia (up to 45.8%), bacterial infections (up to 39.9%), vomiting (up to 39.1%)
  • Malignancies, especially skin, and opportunistic infections

Interactions

  • Aciclovir and valaciclovir: possible competition for tubular secretion in renal impairment, raising levels of both
  • Medicines interfering with enterohepatic recirculation (e.g. cholestyramine, ciclosporin A, antibiotics): possible reduced efficacy
  • Antacids and proton pump inhibitors

Pregnancy and breastfeeding

  • Pregnancy must be avoided: reliable contraception before, during and for six weeks after therapy; two complementary methods preferred
  • Contraindicated in pregnancy unless no suitable alternative; contraindicated during breastfeeding

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • MowelPanacea Biotec Germany Gmbh · 1 register entry
  • Mycophenolat Mofetil SandozSandoz Gmbh · 1 register entry
  • Mycophenolatmofetil AccordAccord Healthcare B.V. · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • MowelPanacea Biotec Germany Gmbh · 1 register entry
  • Mycophenolat1 A Pharma Gmbh, Tillomed Pharma Gmbh, Accord Healthcare B.V. · 3 register entries
  • Mycophenolatmofetil AlAliud Pharma Gmbh · 1 register entry
  • Mycophenolatmofetil AscendAscend Gmbh · 1 register entry
  • Mycophenolatmofetil BiomoBiomo Pharma Gmbh · 1 register entry
  • Mycophenolatmofetil HexalHexal Ag · 1 register entry
  • Mycophenolatmofetil TillomedTillomed Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • CellceptROCHE MÜSTAHZARLARI SAN.A.Ş. · 3 register entries
  • CelptuKOÇSEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • MicosefACTAVİS İLAÇLARI A.Ş. · 2 register entries
  • MikoceptDROGSAN İLAÇLARI SAN. VE TİC. A.Ş. · 1 register entry
  • MikotuKOÇSEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MofeceptKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 4 register entries
  • MyceptBİEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MyforticNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 2 register entries
  • TarbetaxSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 23 more European countries
Belgium
Mycophenolat Mofetil Sandoz
Bulgaria
Микофенолат Мофетил Акорд
Croatia
Mofetilmikofenolat Tillomed, Trixin
Czechia
Mycophenolat Mofetil Sandoz
Denmark
Mycophenolate Mofetil Eql Pharma, Mycophenolate Mofetil Hexal, Mycophenolatmofetil Accord
Estonia
Mycophenolate Mofetil Accord
Finland
Mycophenolate Mofetil Accord, Mycophenolate Mofetil Eql Pharma, Mycophenolate Mofetil Hexal, Mycophenolate Mofetil Sandoz
France
Mycophenolate Mofetil Arrow, Mycophenolate Mofetil Biogaran, Mycophenolate Mofetil Sandoz, Mycophenolate Mofetil Viatris
Iceland
Cellcept, Myclausen, Mycofenolaat Mofetil Stada, Mycophenolate Mofetil Teva, Mycophenolatmofetil Stada, Myfenax, Mykofenolatmofetil Actavis
Ireland
Mycolat, Mycophenolate Mofetil Accord
Italy
Micofenolato Mofetile Accord, Micofenolato Mofetile Ahcl, Micofenolato Mofetile Aurobindo, Micofenolato Mofetile Sandoz, Micofenolato Mofetile Tillomed
Latvia
Mycophenolate Mofetil Accord
Liechtenstein
Cellcept, Myclausen, Mycophenolate Mofetil Teva, Myfenax
Lithuania
Mycophenolate Mofetil Accord
Malta
Mycophenolate Mofetil Ascend
Netherlands
Mycofenolaat Mofetil Accord, Mycofenolaat Mofetil Sandoz, Mycofenolaat Mofetil Viatris, Mycofenolaatmofetil Accord, Mycofenolate Mofetil Aurobindo
Norway
Cellcept, Myclausen, Mycophenolate Mofetil, Mycophenolatemofetil Accord, Myfenax, Mykofenolat Accord, Mykofenolatmofetil Accord
Poland
Mycofit, Mycophenolate Mofetil Sandoz, Mykofenolan Mofetylu Accord
Portugal
Micofenolato De Mofetil Accord, Micofenolato De Mofetil Aristo, Micofenolato De Mofetil Aurovitas, Micofenolato De Mofetil Bluelife, Micofenolato De Mofetil Farmoz, Micofenolato De Mofetil Generis, Micofenolato De Mofetil Tecnigen, Mowel
Romania
Micofenolat Mofetil Sandoz
Slovakia
Mykofenolát Mofetil Sandoz
Spain
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
Sweden
Mycophenolate Mofetil Accord, Mycophenolate Mofetil Eql Pharma, Mycophenolate Mofetil Hexal, Mycophenolate Mofetil Sandoz, Mykofenolatmofetil Accord, Mykofenolatmofetil Actavis

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. CellCept – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/cellcept-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC L04AA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.