| Code | 1533F | ||||||||||
| MA number | 69/0350/25-S | ||||||||||
| Product Form: | aer ors 1x15 ml (fľ.HDPE s dávkov. pumpou) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Naiax Pharma S.L., Spain | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 24.10.2025 |
| Validity: | 24.10.2030 |
| PIL: |
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| SPC: |
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| Safety feature | No |
| Data update: | 27.10.2025 |