其 他 安 全 警 示
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| European Union: European Medicines Agency confirms positive benefit-risk balance for Champix (English Only) |
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The European Medicines Agency has confirmed that the benefit-risk balance for Champix (varenicline) remains positive, despite the results of a recent meta-analysis of the medicine's side effects affecting the heart and blood vessels. The Agency's Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Working Party concluded that the slightly increased risk of cardiovascular events reported by the study's authors does not outweigh the benefits of Champix in helping people to stop smoking. The Committee has asked Pfizer, the marketing-authorisation holder for Champix, to submit a variation to include more information on cardiovascular events in the medicine's product information. Pfizer has informed the Agency that it will submit this application in early August this year. The Committee will review this application in an expedited fashion, aiming to conclude with a recommendation to the European Commission at its plenary meeting of 19-22 September 2011.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/07/news_detail_001314.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1&jsenabled=true
In Hong Kong, Champix (varenicline) Tab 0.5mg and 1mg are registered by Pfizer Corporation HK Ltd. and are prescription medicines. The news has been released by the China SFDA, Health Canada and the US FDA and was posted on the website of Pharmaceutical Service in June 2011 and July 2011. A letter to inform healthcare professionals about the cardiovascular events has been issued on 17 June 2011. Department of Health will keep vigilance against any new safety information in relation to the drug.
Ends/ Friday, July 22, 2011
Issued at HKT 15:30
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