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European Union's CPMP recommends Approval of Caelyx.(Committee for Proprietary Medicinal Products)(Brief Article)
2002 DEC 5 - (NewsRx.com & NewsRx.net) -- Schering-Plough Corp. (SGP) reported that the European Union's (E.U.) Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of Caelyx (pegylated liposomal doxorubicin hydrochloride) as monotherapy for metastatic breast cancer in patients who are at increased cardiac risk.
The CPMP recommendation serves as the basis for a European Commission approval, which typically follows in approximately 3-4 months. Commission approval will result in a marketing authorization with unified labeling that will be valid in all 15 E.U.-member states as well as in Iceland and Norway.
Caelyx is currently marketed in the E.U. for the treatment of ...
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