Code | 8265B | ||||||||||
MA number | 57/0063/16-S | ||||||||||
Product Form: | tbl flm 15x10 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Farmak International Sp. z o.o., Poland | ||||||||||
Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
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: | 22.02.2016 |
PIL: | PIL_Zolpidem FMK 10 mg_08.2023.pdf |
SPC: | SPC_Zolpidem FMK 10 mg_08.2023.pdf |
Safety feature | Yes |
Data update: | 31.07.2023 |