| Name |
Ranolazin HCS 500 mg tablete s produljenim oslobađanjem |
| Marketing Authorisation Number |
HR-H-814668118 |
| Active Substance |
ranolazin |
| Composition |
svaka tableta s produljenim oslobađanjem sadrži 500 mg ranolazina |
| Pharmaceutical Form |
Tableta s produljenim oslobađanjem |
| Manufacturer |
Krka d.d., Novo mesto, Novo Mesto, Slovenija |
| Marketing Authorisation Holder |
HCS BV, H. Kennistraat 53, Edegem, Belgija |
| Marketing Authorisation Date |
08.02.2023 |
| MA Period of Validity |
08.02.2028 |
| Classification Number |
UP/I-530-09/21-01/359 |
| Registration Number |
381-12-01/70-23-09 |
| 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 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
