| Code | 3581E | ||||||||||
| MA number | 25/0110/23-S | ||||||||||
| Product Form: | gel 1x60 g (tuba Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | AXONIA, a.s., Czechia | ||||||||||
| Therapeutic Class: | 25 - ANTIPARASITICA (ANTIPROTOZOICA, ANTIMALARICA) | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | tube Al | ||||||||||
| Route of admin.: | Cutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 12.05.2023 |
| Validity: | 12.05.2028 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 15.05.2023 |