| Code | 9547D | ||||||||||
| MA number | EU/1/22/1625/001 | ||||||||||
| Product Form: | tbl flm 30 (20x150 mg+10x100 mg) (blis.OPA/Al/PVC) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | blister OPA/Al/PVC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 28.01.2022 |
| Validity: | 24.02.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Unknown |
| Data update: | 01.03.2023 |
