| Code | 0150F | ||||||||||
| MA number | 31/0075/25-S | ||||||||||
| Product Form: | tbl flm 90x10 mg/10 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 31 - HYPOLIPIDAEMICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10b fixed combination application |
| MA issued: | 22.05.2025 |
| Validity: | 22.05.2030 |
| MA renewed: | Renewal application submitted |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Rozetin_08.2025.pdf
|
| SPC: |
SPC_Rozetin_08.2025.pdf
|
| Safety feature | Yes |
| Data update: | 28.05.2025 |
