其 他 安 全 警 示
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| European Union: European Medicines Agency concludes that benefit-risk balance of Revlimid remains positive(English Only) |
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Revlimid (lenalidomide), particularly improved survival, continue to outweigh the risks but recommended that the prescribing information for Revlimid be updated with a warning and advice to doctors on the risk of new cancers. Doctors are also reminded that the current review of the benefits and risks of Revlimid only covers the approved patient population. The Committee’s conclusion does not cover its use outside of the current authorised indication.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/09/news_detail_001343.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, lenalidomide is registered as Revlimid Cap 5mg, 10mg, 15mg and 25mg. They are registered by Celgene Ltd and are prescription-only medicines. The above safety information was released by the US FDA and the UK MHRA and was posted on the website of Pharmaceutical Service on 9 April and 5 May 2011. A letter to inform healthcare professionals was issued on 9 April 2011. In view of CHMP’s recommendation, the issue will be discussed in the upcoming meeting of the Registration Committee of Pharmacy and Poisons Board.
Ends/ Saturday, September 24, 2011
Issued at HKT 12:30
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