Article: Schering-Plough Announces EU Approval of CAELYX(R) in Metastatic Breast Cancer.

Schering-Plough Corporation today announced that the European Commission of the European Union (EU) has granted centralized marketing authorization to CAELYX(R) (pegylated liposomal doxorubicin hydrochloride) as monotherapy for metastatic breast cancer in patients who are at increased cardiac risk.

Commission approval results in marketing authorization with unified labeling that is immediately valid in all 15 EU-Member States as well as in Iceland and Norway. The Commission's decision follows its recommendation for approval in October 2002 by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal ...

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