Code | 44078 | ||||||||||
MA number | EU/1/96/005/004 | ||||||||||
Product Form: | tbl flm 150 (3x50)x500 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: |
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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: | 13.05.1997 |
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: | 18.10.2019 |