| Code | 2291F | ||||||||||
| MA number | 57/0428/25-S | ||||||||||
| Product Form: | tbl flm 20x7,5 mg (blis.Al/PVC/PVDC) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AS Olpha, Latvia | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister Al/PVC/PVDC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 22.12.2025 |
| Validity: | 22.12.2030 |
| PIL: |
PIL_Zopiclone Olpha 7,5 mg tbl flm_12.2025.pdf
|
| SPC: |
SPC_Zopiclone Olpha 7,5 mg tbl flm_12.2025.pdf
|
| Safety feature | Yes |
| Data update: | 02.01.2026 |
