Ramipril/amlodipin Sandoz 5 mg/10 mg tvrde kapsule
| Name | Ramipril/amlodipin Sandoz 5 mg/10 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-214437792 |
| Active Substance | ramipril amlodipinbesilat |
| Composition | svaka tvrda kapsula sadrži 5 mg ramiprila i 10 mg amlodipina (13,868 mg u obliku amlodipinbesilata) |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | Zaklady Farmaceutyczne Polpharma S.A., Starogard Gdanski, Poljska Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 14.05.2024 |
| MA Period of Validity | 14.05.2029 |
| Classification Number | UP/I-530-09/21-01/185 |
| Registration Number | 381-12-01/70-24-07 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C09BB07 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
