| Code | 9682C | ||||||||||
| MA number | 24/0197/17-S | ||||||||||
| Product Form: | sol por 1x120 ml (fľ.skl.jantárová s detským bezpeč.uzáver.+25 ml odmerka) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Menarini International Operations Luxembourg S.A., Luxembourg | ||||||||||
| Therapeutic Class: | 24 - ANTIHISTAMINICA, HISTAMIN | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | amber glass bottle | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 27.07.2017 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Omarit 2,5 mgml perorálny roztok_03.2023.pdf
|
| PIL: |
PIL_Omarit 2,5 mgml perorálny roztok_03.2023.pdf
|
| Safety feature | Yes |
| Data update: | 18.08.2022 |
