| Code | 8576C | ||||||||||
| MA number | 58/0267/18-S | ||||||||||
| Product Form: | tbl flm 90x10 mg/4 mg/1,25 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 |
