| Code | 5473D | ||||||||||
| MA number | 69/0194/20-S | ||||||||||
| Product Form: | aer ors 1x20 ml (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Geiser Pharma S.L., Spain | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 02.09.2020 |
| Validity: | 02.09.2025 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_SERSPARY_09/2023.pdf
|
| SPC: |
SPC_SERSPARY_09/2023.pdf
|
| Safety feature | No |
| Data update: | 18.09.2023 |
