| Code | 9998C | ||||||||||
| MA number | EU/1/16/1129/003 | ||||||||||
| Product Form: | tbl flm 10x245 mg (blis.OPA/Al/PE/Desiccant/PE-Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 08.12.2016 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 11.10.2024 |
