CellCept - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

mycophenolate mofetil

Opinion

On 14 November 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product CellCept.

The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

The CHMP adopted an extension to an existing indication to include treatment of children from 1 year of age with CellCept 500 mg film-coated tablets, 250 mg hard capsules and 1 g / 5 ml powder for oral suspension.

For information, the full indication will be as follows:¹

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹New text in bold.

CHMP post-authorisation summary of positive opinion for CellCept (II-170-G)

AdoptedReference Number: EMA/178674/2024

Key facts

• Name of medicine:
  CellCept
• EMA product number:
  EMEA/H/C/000082
• Active substance:
  mycophenolate mofetil
• International non-proprietary name (INN) or common name:
  mycophenolate mofetil
• Therapeutic area (MeSH):
  Graft Rejection
• Anatomical therapeutical chemical (ATC) code:
  L04AA06
• Marketing authorisation holder:
  Roche Registration GmbH
• Date of opinion:
  14/11/2024
• Status:
  Positive