Code | 92955 | ||||||||||
MA number | 57/0278/05-S | ||||||||||
Product Form: | tbl flm 20x10 mg (blister PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Viatris Limited, Ireland | ||||||||||
Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 09.09.2005 |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Zolpidem Viatris 10 mg_tbl flm_09_2024.pdf |
PIL: | PIL_Zolpidem Viatris 10 mg_tbl flm_09_2024.pdf |
Safety feature | Yes |
Data update: | 25.09.2024 |