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GlaxoSmithKline (GSK) has withdrawn its application for a centralised European marketing authorisation for Zunrisa (casopitant mesylate), 50mg and 150mg tablets.
Zunrisa is being developed for use in the prevention of post-operative and chemotherapy-induced nausea and vomiting.
GSK says that more safety data is needed to support the registration of casopitant worldwide, and that it will take some time to produce these data.
The application was submitted to the European Medicines Agency on 2 July last year 2008, and was being reviewed by the agency’s committee for medicinal products for human use (CHMP).
Copyright © Press Association 2009
Casopitant mesylatehe trial, The Lancet
