| Code | 6390D | ||||||||||
| MA number | EU/1/20/1500/001 | ||||||||||
| Product Form: | tbl flm 2x20 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Roche Registration GmbH, Germany | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: |
|
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| Shelf life: | 60 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 07.01.2021 |
| Validity: | 07.01.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 18.01.2023 |
