Code | 9355D | ||||||||||
MA number | 83/0047/19-S | ||||||||||
Product Form: | sus por 1x30 ml (fľ.HDPE+PP dáv.pumpa) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Alpen Pharma GmbH, Germany | ||||||||||
Therapeutic Class: | 83 - VASODILATANTIA | ||||||||||
ATC: |
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Shelf life: | 18 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 22.02.2019 |
Validity: | 22.02.2024 |
MA renewed: | Renewal application submitted |
SPC: | SPC_Azurvig 12,5 mg_dávka pumpy, perorálna suspenzia_04_2023.pdf |
PIL: | PIL_Azurvig 12,5 mg_dávka pumpy, perorálna suspenzia_04_2023.pdf |
Safety feature | Yes |
Data update: | 29.12.2021 |