| Code | 1644F | ||||||||||
| MA number | 58/0355/25-S | ||||||||||
| Product Form: | cps dur 50x10 mg/5 mg (blis.Al/OPA/Al/PVC) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Vale Pharmaceuticals Limited, Ireland | ||||||||||
| Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | blister Al/OPA/Al/PVC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10b fixed combination application |
| MA issued: | 19.11.2025 |
| Validity: | 19.11.2030 |
| PIL: |
PIL_Ramipril Amlodipine Vale 5mg5mg, 5mg10mg, 10mg5mg, 10mg10mg_10_2025.pdf
|
| SPC: |
SPC_Ramipril Amlodipine Vale 5mg5mg, 5mg10mg, 10mg5mg, 10mg10mg_10_2025.pdf
|
| Safety feature | Yes |
| Data update: | 20.11.2025 |
