Code | 3781E | ||||||||||
MA number | 18/0149/23-S | ||||||||||
Product Form: | tbl plg 60x500 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
|
||||||||||
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: | 05.07.2023 |
Validity: | 05.07.2028 |
PIL: | PIL_Stadamet retard tablety s predĺženým uvoľňovaním_06_2023.pdf |
SPC: | SPC_Stadamet retard 500 mg tablety s predĺženým uvoľňovaním_06_2023.pdf |
Safety feature | Yes |
Data update: | 06.07.2023 |