Code | 3824D | ||||||||||
MA number | 18/0056/20-S | ||||||||||
Product Form: | tbl flm 56x50 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 16.03.2020 |
Validity: | 16.03.2025 |
MA renewed: | Renewal application submitted |
Dokument: | VHS_súhrn_Sitagavia 18_0055-57_20-S.pdf |
Dokument: | VHS_Sitagavia 18_0055-57_20-S.pdf |
PIL: | PIL_Sitagavia_04.2022.pdf |
SPC: | SPC_Sitagavia_01.2023.pdf |
Safety feature | Yes |
Data update: | 24.01.2023 |