CellCept (mycophenolate mofetil)
- Region
- 🇪🇺 EU
- Active substance
- mycophenolate mofetil
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Graft Rejection
- EU approval
- Wed 14 Feb 1996
- Application
- EMEA/H/C/000082
- ATC
- L04AA06
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Myfenax Authorised · Teva B.V.
- 🇪🇺 Myclausen Authorised · Passauer Pharma GmbH
- 🇪🇺 Mycophenolate mofetil Teva Authorised · Teva Pharma B.V.
Follow CellCept
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.