| Code | 6435E | ||||||||||
| MA number | 69/0118/24-S | ||||||||||
| Product Form: | aer nau 1x18 g (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Nasal use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 07.06.2024 |
| Validity: | 07.06.2029 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Metsandia, 50 µg, aer nau_OTC_11/2024.pdf
|
| PIL: |
PIL_Metsandia, 50 µg, aer nau_Rx_11/2024.pdf
|
| SPC: |
SPC_Metsandia_02/2025.pdf
|
| Safety feature | Yes |
| Data update: | 20.08.2024 |
