Halibrell 375 mg tablete s produljenim oslobađanjem
| Name | Halibrell 375 mg tablete s produljenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-132499376 |
| Active Substance | ranolazin |
| Composition | jedna tableta sadrži 375 mg ranolazina |
| Pharmaceutical Form | Tableta s produljenim oslobađanjem |
| Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija
Elpen Pharmaceutical Co.Inc. (SA), Pikermi, Attica, Grčka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 31.01.2025 |
| MA Period of Validity | 31.01.2030 |
| Classification Number | UP/I-530-09/22-01/19 |
| Registration Number | 381-12-01/70-25-07 |
| 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 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
