| Code | 4977E |
| MA number | EU/1/23/1738/002 |
| Product Form: | tbl flm 30x50 mg (blis.PVC/PCTFE/Al) |
| MA Status: | Ex - Conditional centralised marketing authorisation |
| Type of procedure: | EU |
| Shelf life: | 24 |
| Container: | blister PVC/PCTFE/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: | 30.10.2023 |
| Validity: | 30.10.2024 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 07.11.2023 |
