| Name |
Ranolazin HCS 375 mg tablete s produljenim oslobađanjem |
| Marketing Authorisation Number |
HR-H-824087633 |
| Active Substance |
ranolazin |
| Composition |
svaka tableta s produljenim oslobađanjem sadrži 375 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-530-09/21-01/358 |
| Registration Number |
381-12-01/70-23-09 |
| Prescription |
na recept |
| Type of prescription |
ponovljivi recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
C01EB18 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
