CPMP July Plenary Meeting

4 August 1997

At the European Agency for the Evaluation of Medicinal Products'Committee for Proprietary Medicinal Products 29th plenary meeting on July 22-23, a positive opinion on a centralized application for Genzyme's Cerezyme (imiglucerase), a therapy for patients with type I Gaucher's disease, was adopted.

The CPMP also adopted by consensus nine positive opinions for centralized type II variations and 10 positive opinions for centralized type I variations following the type II procedure.

Since the CPMP July 1997 meeting, the European Commission has granted a marketing authorization for Mylan's Cystagon (mercaptamine) for the treatment of nephropathic cystinosis, Sipaco International of Portugal's Orlaam (levalcylmethadol) for substitution maintenance treatment of opiate addiction, Novartis' Revasc (desirudin), an antithrombotic agent and a new formulation of Boehringer Mannheim's peptide NeoRecormon (epoetin beta).

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