Code | 8587C | ||||||||||
MA number | 58/0268/18-S | ||||||||||
Product Form: | tbl flm 60x10 mg/8 mg/2,5 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
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: | 23.08.2018 |
Validity: | 23.08.2023 |
MA renewed: | Renewal application submitted |
PIL: | PIL_Roxiper_06/2023.pdf |
SPC: | SPC_Roxiper_06/2023.pdf |
Safety feature | Yes |
Data update: | 05.06.2019 |