| Code | 0610F | ||||||||||
| MA number | EU/1/25/1943/001 | ||||||||||
| Product Form: | tbl flm 84(4x21)x50 mg/20 mg/4 mg (blis. PCTFE/PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Vertex Pharmaceuticals (Ireland) Limited, Ireland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PCTFE/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: | 30.06.2025 |
| Validity: | 30.06.2030 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 15.07.2025 |
