Name |
Tezulix 375 mg tablete s produljenim oslobađanjem |
Marketing Authorisation Number |
HR-H-271919003 |
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 |
Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
Marketing Authorisation Date |
07.02.2023 |
MA Period of Validity |
07.02.2028 |
Classification Number |
UP/I-530-09/21-01/355 |
Registration Number |
381-12-01/171-23-08 |
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 |