Code | 0274D | ||||||||||
MA number | 31/0011/19-S | ||||||||||
Product Form: | tbl flm 30x5 mg/10 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
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 |
Validity: | 25.01.2024 |
MA renewed: | Renewal application submitted |
PIL: | PIL_Rosazimib tbl flm_07.2023.pdf |
SPC: | SPC_Rosazimib tbl flm_07.2023.pdf |
Safety feature | Yes |
Data update: | 18.08.2022 |