| Code | 0282D | ||||||||||
| MA number | 31/0012/19-S | ||||||||||
| Product Form: | tbl flm 28x10 mg/10 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| 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: | 25.01.2019 |
| PIL: |
PIL_Rosazimib tbl flm_09.2024.pdf
|
| SPC: |
SPC_Rosazimib tbl flm_09.2024.pdf
|
| Safety feature | Yes |
| Data update: | 06.09.2024 |
