| Code | 2183E | ||||||||||
| MA number | 42/0235/22-S | ||||||||||
| Product Form: | sir 1x100 ml/10 g (fľ.skl.hnedá) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Aflofarm Farmacja Polska Sp. z o.o., Poland | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | brown glass bottle | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 27.10.2022 |
| Validity: | 27.10.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 07.11.2022 |