| Code | 9554C | ||||||||||
| MA number | 31/0361/18-S | ||||||||||
| Product Form: | tbl flm 60x20 mg/10 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| 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 8(3) application - known active substance |
| MA issued: | 26.10.2018 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_ROZOR_07.2023.pdf
|
| SPC: |
SPC_ROZOR_07.2023.pdf
|
| Safety feature | Yes |
| Data update: | 21.11.2022 |
