Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Bicaluplex
Also marketed in the EU under the name(s): Bicalutamid TEVA, Bicalutamide, Bicalutamide TEVA, Bicamid-GRY
Active substance: bicalutamide
Indication: Bicalutamide is an oral anti-androgen used in the management of prostate cancer.
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/11/2007 Referral EMEA/H/A-29/857 (2007)5816 of 22/11/2007