Code | 0329D | ||||||||||
MA number | 18/0022/19-S | ||||||||||
Product Form: | tbl plg 60x500 mg (blis.Al/PVC) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Teva B.V., Netherland | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister Al/PVC | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 29.01.2019 |
Validity: | 29.01.2024 |
MA renewed: | Renewal application submitted |
PIL: | PIL_Metformin Teva XR_10.2022.pdf |
SPC: | SPC_Metformin Teva XR_10.2022.pdf |
Safety feature | Yes |
Data update: | 20.05.2020 |