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PRODUCT DETAIL

Mirovian XR 500 mg

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:
A ALIMENTARY TRACT AND METABOLISM
A10 DRUGS USED IN DIABETES
A10B Blood glucose lowering drugs, excl. insulins
A10BA Biguanides
A10BA02 Metformin
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
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