Euro Union CPMP September Meeting

The European Union's Committee for Proprietary Medicinal Products heldits 30th plenary meeting at the European Medicines Evaluation Agency in London, September 23-24.

The meeting adopted by consensus: a positive opinion on a centralized application for a product containing a new active substance (Part B) indicated for the treatment of HIV infection; six positive opinions for centralized type I variations following the type II procedure; and five positive opinions for centralized type II variations.

Since July's plenary meeting, the European Commission has granted marketing authorizations to: Roche's Tasmar (tolcapone) for use in Parkinson's disease; INFAI's Helicobacter Test INFAI (13C-urea) for in vivo diagnosis of Helicobacter pylori infection; SmithKline Beecham's Infanrix-HepB (DTPa-HB vaccine) for active immunization of infants against diphtheria, tetanus, pertussis and hepatitis B; Genetics Institute's Benefix (nonacog alpha) for control and prevention of hemorrhagic episodes and prophylaxis of hemophilia B and factor IX deficiency; and Bristol-Myers Squibb's Aprovel/Karvea (irbesartan) for essential hypertension.