Ranolazin Accord 375 mg tablete s produljenim oslobađanjem
| Name | Ranolazin Accord 375 mg tablete s produljenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-188739599 |
| Active Substance | ranolazin |
| Composition | jedna tableta sadrži 375 mg ranolazina |
| Pharmaceutical Form | Tableta s produljenim oslobađanjem |
| Manufacturer | Accord Healthcare B.V., Utrecht, Nizozemska
Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska Pharmadox Healthcare Limited, Paola, Malta |
| Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date | 17.05.2024 |
| MA Period of Validity | 17.05.2029 |
| Classification Number | UP/I-530-09/21-01/293 |
| Registration Number | 381-12-01/70-24-09 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C01EB18 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
