EU CPMP Plenary Meeting In April

28 April 1996

The European Commission Committee for Proprietary Medicinal Products held its 15th plenary meeting on April 16-18 at the European Medicines Evaluation Agency in London.

- centralized procedures: the CPMP adopted a positive opinion by consensus for a Part B anti-HIV medicinal product, the application for which was submitted in July 1995, The CPMP's total review time was 152 days; - a new application under the centralized procedure was assigned to a rapporteur and a co-rapporteur following confirmation of Part B status;

- drug safety: an ad hoc expert group report on the potential risk associated with medicinal products in relation to bovine spongiform encephalopathy was considered and adopted, and the final EMEA opinion forwarded to the Commission; position statements were adopted on - oral contraceptives containing desogestrel or gestodene, and - calcium antagonists, further to discussions in the Pharmacovigilence Working Party on recent epidemiological evidence which suggests these substances may be associated with increased risk of cardiovascular events and mortality. The statement included additional warnings and contraindications. The report will be communicated to marketing authorization holders by the member states' national competent authorities;

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