| 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 | ||||||||||
| 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 |
