| Code | 9629E | ||||||||||
| MA number | 57/0139/25-S | ||||||||||
| Product Form: | tbl flm100x3,75 mg (blis. PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | UAB Baltijos Bite, Lithuania | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| 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: | 29.05.2025 |
| Validity: | 29.05.2030 |
| SPC: |
SPC_Zopiclone Baltijos Bite_05 2025.pdf
|
| PIL: |
PIL_Zopiclone Baltijos Bite_05 2025.pdf
|
| Safety feature | Yes |
| Data update: | 04.06.2025 |
