Code | 5649D | ||||||||||
MA number | 18/0225/20-S | ||||||||||
Product Form: | tbl plg 30x500 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Zentiva, k.s., Czechia | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 20.10.2020 |
Validity: | 20.10.2025 |
MA renewed: | Renewal application submitted |
SPC: |
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PIL: |
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Safety feature | Yes |
Data update: | 18.03.2021 |