Name |
Bixalan 150 mg filmom obložene tablete |
Former Name |
Bikalutamid Edicta 150 mg tablete |
Marketing Authorisation Number |
HR-H-861827242 |
Active Substance |
bikalutamid |
Composition |
jedna filmom obložena tableta sadrži 150 mg bikalutamida |
Pharmaceutical Form |
filmom obložena tableta |
Manufacturer |
Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
Marketing Authorisation Holder |
Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
Marketing Authorisation Date |
26.08.2016 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/15-02/413 |
Registration Number |
381-12-01/30-16-02 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
L02BB03 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |