| Code | 7425E | ||||||||||
| MA number | 24/0201/24-S | ||||||||||
| Product Form: | aer nau 1x23 g (fľ.skl.jantár) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 24 - ANTIHISTAMINICA, HISTAMIN | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| 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: | 16.09.2024 |
| Validity: | 16.09.2029 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Lutonaze_09_2024.pdf
|
| PIL: |
PIL_Lutonaze_09_2024.pdf
|
| Safety feature | Yes |
| Data update: | 19.09.2024 |
