| Code | 4027E | ||||||||||
| MA number | 24/0175/23-S | ||||||||||
| Product Form: | aer nau 3x23 g/120 vstreknutí (fľ.skl.jantárová-multibal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| Therapeutic Class: | 24 - ANTIHISTAMINICA, HISTAMIN | ||||||||||
| ATC: |
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| Container: | amber glass bottle | ||||||||||
| Route of admin.: | Nasal use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 21.07.2023 |
| Validity: | 21.07.2028 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Dymol_07_2023.pdf
|
| PIL: |
PIL_Dymol_09/2024.pdf
|
| Safety feature | Yes |
| Data update: | 26.07.2023 |
