Code | 5652D | ||||||||||
MA number | 18/0225/20-S | ||||||||||
Product Form: | tbl plg 60x500 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Zentiva, k.s., Czechia | ||||||||||
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: | 20.10.2020 |
SPC: | SPC_Mirovian XR 500 mg_03.2023.pdf |
PIL: | PIL_Mirovian XR_04.2024.pdf |
Safety feature | Yes |
Data update: | 05.11.2024 |