EMA takes further action at Ben Venue
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EMA takes further action at Ben Venue The EMA has issued further interim recommendations for managing the shortcomings in quality assurance identified at Ben Venue Laboratories’ Ohio, US, manufacturing site.* The agency has enacted a precautionary recall of batches of Ecalta (anidulafungin) and Luminity (perflutren) manufactured at Ben Venue, which after review by the CHMP, have been deemed to be not essential. Ceplene (histamine dihdrochloride) and Torisel (temsirolimus) are only manufactured by Ben Venue, and the CHMP considers these drugs to be essential for some cancer patients, and recommends that supplies should remain available. However, healthcare professionals are advised to visually inspect the vials for the presence of particles prior to administration. * see also Reactions 1380 p2; 809131539 EMA. European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories. Media Release : 9 Dec 2011. Available from: URL: http:// 809131980 www.ema.europa.eu
0114-9954/10/1382-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved
Reactions 17 Dec 2011 No. 1382
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