Code | 0679C | ||||||||||
MA number | EU/1/16/1108/001 | ||||||||||
Product Form: | tbl flm 14x5 mg/10 mg (blis.PA/Al/PVC-Al - kalend.bal.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | AstraZeneca AB, Sweden | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10b fixed combination application |
MA issued: | 15.07.2016 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 26.05.2021 |