| Code | 8103D | ||||||||||
| MA number | 58/0203/21-S | ||||||||||
| Product Form: | cps dur 90x20 mg/5 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| 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: | 31.07.2021 |
| SPC: |
SPC_Rosuramlon_09/2023.pdf
|
| PIL: |
PIL_Rosuramlon_cps dur_05_2024.pdf
|
| Safety feature | Yes |
| Data update: | 13.01.2026 |
