Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Dexrazoxane
Also marketed in the EU under the name(s): Cardioxane, Cyrdanax, DEXRAZOXANE CYATHUS, Enaxozar, Procard
Active substance: Dexrazoxane
Indication: Prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or metastatic adult breast cancer patients
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
15/09/2011 Referral EMEA/H/A-31/1275 (2011)6519 of 13/09/2011
13/01/2015 PSUSA - Modification EMEA/H/C/PSUSA/1001/201402 (2015)110 of 12/01/2015