Code | 3713C | ||||||||||
MA number | EU/1/17/1172/001 | ||||||||||
Product Form: | sol por 1x60 ml/120 mg (fľ.jant.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Oresund Pharma ApS, Denmark | ||||||||||
Therapeutic Class: | 29 - ANTIRHEUMATICA, ANTIPHLOGISTICA, ANTIURATICA | ||||||||||
ATC: |
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Shelf life: | 18 | ||||||||||
Container: | amber glass bottle | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 29.03.2017 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 25.01.2022 |