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PRODUCT DETAIL

Zolpidem Xantis 10 mg

Code 8263B
MA number 57/0063/16-S
Product Form: tbl flm 7x10 mg (blis.PVC/PVDC/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
Therapeutic Class: 57 - HYPNOTICA, SEDATIVA
ATC:
N NERVOUS SYSTEM
N05 PSYCHOLEPTICS
N05C HYPNOTICS AND SEDATIVES
N05CF Benzodiazepine related drugs
N05CF02 Zolpidem
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 Xantis 10 mg_06.2020.docx  
SPC: SPC_Zolpidem Xantis 10 mg_tbl flm_12.2021.pdf  
Safety feature Yes
Data update: 21.12.2021
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