| Code | 5202E | ||||||||||
| MA number | 57/0278/05-S | ||||||||||
| Product Form: | tbl flm 10x10 mg (fľ.HDPE s PP uzáver.) | ||||||||||
| 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 |
