| Code | 32503 | ||||||||||
| MA number | EU/1/12/751/001 | ||||||||||
| Product Form: | tbl flm 56(7x8)x1x240 mg (blis.Al/Al-perf.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Roche Registration GmbH, Germany | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister Al/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 17.02.2012 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC_Zelboraf_final 20151019.pdf
|
| Safety feature | Yes |
| Data update: | 12.02.2021 |
