🇪🇺 Mycophenolate mofetil, adjusted dose in European Union

EMA authorised Mycophenolate mofetil, adjusted dose on 14 February 1996

Marketing authorisation

EMA — authorised 14 February 1996

  • Application: EMEA/H/C/000082
  • Marketing authorisation holder: Roche Registration GmbH
  • Local brand name: CellCept
  • 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.
  • Status: approved

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Mycophenolate mofetil, adjusted dose in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Mycophenolate mofetil, adjusted dose approved in European Union?

Yes. EMA authorised it on 14 February 1996.

Who is the marketing authorisation holder for Mycophenolate mofetil, adjusted dose in European Union?

Roche Registration GmbH holds the EU marketing authorisation.