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Article: Schering-Plough Reports European Union's CPMP Recommends Approval of CAELYX(R) in Metastatic Breast Cancer.
- Article from:
- PR Newswire
- Article date:
- October 18, 2002
CopyrightCOPYRIGHT 2002 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Schering-Plough Corporation today reported that the European Union's (EU) 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(R) (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 three to four months. Commission approval will result in a Marketing Authorization with unified labeling that will be valid in all 15 EU-Member ...