The 19th plenary meeting of the European Commission's Committee for Proprietary Medicinal Products, held September 10-11 at the European Medicines Evaluation Agency in London, heard that 19 Community Marketing Authorizations have now been granted by the Commission.
This follows the recent adoption of authorizations for SmithKline Beecham's Tritanrix HB10 (combination vaccine), Glaxo Wellcome's Epivir (lamivudine), Sorin's Tecnemab (antimelanoma antibody), Boehringer Mannheim's Rapilysin (reteplase), Galenus Mannheim's Ecokinase (teleplase) and Abbott's Norvir (ritonavir). The new European Public Assessment Reports will be made available.
Seven new applications have been assigned to rapporteurs and co-rapporteurs under the centralized procedure (one Part A and six Part B), the meeting heard, and it adopted three scientific advices by consensus, with break-out sessions held with two companies. 10 new mutual recognition procedures, plus eight Type I and eight Type II variation procedures were finalized recently.
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