| Name |
Bikalis 50 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-103266585 |
| Active Substance |
bikalutamid |
| Composition |
jedna filmom obložena tableta sadrži 50 mg bikalutamida |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
Genepharm S.A., Pallini Attiki, Grčka |
| Marketing Authorisation Holder |
Stada d.o.o., Hercegovačka 14, Zagreb |
| Marketing Authorisation Date |
29.02.2016 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/14-02/516 |
| Registration Number |
381-12-01/70-16-06 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
L02BB03 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |