CPMP Ends Review Of EU Concertation Procedures

Europe's Committee for Proprietary Medicinal Products held its 23rdplenary meeting on January 21-22 at the European Medicines Evaluation Agency in London. It adopted by consensus a positive opinion for a medicinal product (Part B) containing a new active substance for substitution maintenance treatment of opiate addiction.

This concluded the centralized review of the 18 ex-concertation procedures which were transferred to the EMEA in January 1995. The opinion will be forwarded to the European Commission. The Committee also adopted by consensus a positive opinion for a centralized Type II variation procedure concerning a recent Community marketing authorization.

EMA Granted To SB's Evotopin Since the CPMP's December meeting, the European Commission has granted a marketing authorization to SmithKline Beecham's Evotopin (topotecan), for the treatment of metastatic ovarian cancer. The European Public Assessment Report will be made available by the EMEA.