Code | 41519 | ||||||||||
MA number | EU/1/96/005/006 | ||||||||||
Product Form: | plu por 1x35 g (fľa. HDPE) (1 g/5 ml) | ||||||||||
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: | 24 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application |
MA issued: | 26.02.1999 |
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: | 15.06.2018 |