| Code | 0870F | ||||||||||
| MA number | 42/0276/25-S | ||||||||||
| Product Form: | tbl 50x1000 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Ewopharma International, s.r.o., Slovakia | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 17.09.2025 |
| Validity: | 17.09.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 22.09.2025 |