| Code | 4978E | ||||||||||
| MA number | EU/1/23/1738/003 | ||||||||||
| Product Form: | tbl flm 84x50 mg (blis.PVC/PCTFE/Al) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Eli Lilly Nederland B.V., Netherland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| 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: | 31.10.2025 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 07.05.2025 |
