| Code | 2856F | ||||||||||
| MA number | 31/0079/26-S | ||||||||||
| Product Form: | tbl flm 60x40 mg/10 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Viatris Healthcare Limited, Ireland | ||||||||||
| Therapeutic Class: | 31 - HYPOLIPIDAEMICA | ||||||||||
| ATC: |
|
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| Shelf life: | 30 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | [Rozšírenie radu N, Z, D, B] |
| MA issued: | 05.03.2026 |
| Validity: | 05.03.2031 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_ROZOR_03_2026.pdf
|
| PIL: |
PIL_ROZOR_03_2026.pdf
|
| Safety feature | Yes |
| Data update: | 06.03.2026 |
