| Code | 4441B | ||||||||||
| MA number | EU/1/11/717/002 | ||||||||||
| Product Form: | cps mol 90 (3x30x1)x20 mg (blis.PVC/PA/Al/PVC/Al-jednotk.bal.) (multibal.) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Pfizer Europe MA EEIG, Belgium | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| 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: | 16.11.2011 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Vyndaqel_Príručka pre predpisujúceho lekára.pdf
|
| Safety feature | Yes |
| Data update: | 27.01.2022 |
