| Name |
Bixalan 50 mg filmom obložene tablete |
| Former Name |
Bikalutamid Edicta 50 mg tablete |
| Marketing Authorisation Number |
HR-H-348905269 |
| Active Substance |
bikalutamid |
| Composition |
jedna filmom obložena tableta sadrži 50 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-530-09/15-02/412 |
| Registration Number |
381-12-01/30-16-04 |
| 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 |
