| Code | 5616D | ||||||||||
| MA number | EU/1/96/005/007 | ||||||||||
| Product Form: | cps dur 300 (3x100)x250 mg (blis.PVC/Alu - multibal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Roche Registration GmbH, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application |
| MA issued: | 14.02.1996 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC_Cellcept_risk of teratogenity_FINAL.pdf
|
| Dokument: |
DHPC_CellCept_12 12 2014.pdf
|
| Dokument: |
CellCept PRCA DHCP 18 05 09.pdf
|
| Safety feature | Yes |
| Data update: | 25.09.2020 |
