| Code | 0994F | ||||||||||
| MA number | EU/1/25/1966/002 | ||||||||||
| Product Form: | tbl flm 90x200 mg/25 mg/25 mg (blis.OPA/Al/PE/vysúšadlo/HDPE-Al/PE) | ||||||||||
| 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: | 12 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 19.08.2025 |
| Validity: | 19.08.2030 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 05.09.2025 |
