Code | 2305E | ||||||||||
MA number | 18/0273/22-S | ||||||||||
Product Form: | tbl plg 84x30 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Medreg s.r.o., Czechia | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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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: | 29.11.2022 |
Validity: | 29.11.2027 |
SPC: | SPC_Gliclazide Medreg 30 a 60 mg_11 2022.pdf |
PIL: | PIL_Gliclazide Medreg 30 mg_10.2023.pdf |
Safety feature | Yes |
Data update: | 06.12.2022 |