Code | 10900 | ||||||||||
MA number | 57/0520/11-S | ||||||||||
Product Form: | tbl flm 30x10 mg (blis.PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Vitabalans Oy, Finland | ||||||||||
Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Container: | blister PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 20.09.2011 |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
SPC: | SPC_Zolpidem Vitabalans 10 mg filmom obalené tablety_03_2024.pdf |
PIL: | PIL_Zolpidem Vitabalans 10 mg filmom obalené tablety_03_2024.pdf |
Safety feature | Yes |
Data update: | 04.10.2019 |