| Code | 3349B | ||||||||||
| MA number | EU/1/14/981/001 | ||||||||||
| Product Form: | tbl flm 27 (4x10 mg+4x20 mg+19x30 mg (blis.PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Amgen Europe B.V., Netherland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/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: | 15.01.2015 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC_Otezla_7_11_2016.pdf
|
| Safety feature | Yes |
| Data update: | 05.11.2024 |
