| Code | 7618E | ||||||||||
| MA number | 69/0254/24-S | ||||||||||
| Product Form: | aer ors 1x20 ml/153 vstreknutí (fľ.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Bayer, spol. s r.o., Slovakia | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass bottle | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 30.09.2024 |
| Validity: | 30.09.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| SPC: |
SPC_ASPEGOLA 6,0 mg_ml + 4,46 mg_ml + 2,23 mg_ml orálny roztokový sprej_09_2024.pdf
|
| PIL: |
PIL_ASPEGOLA 6,0 mg_ml + 4,46 mg_ml + 2,23 mg_ml orálny roztokový sprej_09_2024.pdf
|
| Safety feature | No |
| Data update: | 02.10.2024 |
