Pharmaceuticals - Community Register


List of referrals for human medicinal products


Product name: Bicalutamide
Also marketed in the EU under the name(s): Alidex, Beluclas, Bicadex, Bicaludex, Bicalut, Bicalutamid Bicalutamid "Dermapharm", Bicalutamid "Genericon", Bicalutamid Alternova, Bicalutamid CTArzneimittel, Bicalutamid Orion, Bicalutamid Ratiopharm, Bicalutamid Ribosepharm, Bicalutamida Etsi, Bicalutamida Generis, Bicalutamida Prostec, Bicalutamide, Bicalutamide Kiron, Bicalutamide Peseri, Bicalutamidum Bicalutamidum Genthon, Bicamale, Bicasel, Bicatad, Bicavan, Biclad, Bikalutamidi Synthon, Bilutamid, Calumid, Casodex, Crilame, Duralutamide, Grelutamide, Helmalut, Henlutamide, Inatamide, Konlutamide, Lukasenomid, Lutamide, Saputamide, Skylutamide, Timutamide, Verodex
INN: 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
05/09/2007 Referral EMEA/H/A-31/767 (2007)4190 of 03/09/2007