The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail

Casodex 50 mg film-coated tablets

PCO Manufacturing Ltd.PPA0465/144/001

Main Information

Trade NameCasodex 50 mg film-coated tablets
Active SubstancesBicalutamide
Dosage FormFilm-coated tablet
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/144/001

Group Information

ATC CodeL02BB Anti-androgens
L02BB03 bicalutamide


License statusAuthorised
Licence Issued02/07/2004
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis authorisation permits the holder to parallel-distribute product marketed in Ireland under the product authorisation number PA0970/004/001.
Marketing StatusUnknown


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available

Generics Information

Interchangeable List CodeIC0137-023-003
Interchangeable List DocumentPDF of Interchangeable List
« Back