Updated on 25 January 2013
Novartis withdraws marketing authorization application for Ruvise
Singapore: Novartis Europharm has decided to withdraw its application for a centralized marketing authorization for the medicine Ruvise (imatinib mesilate), 100 and 400 mg film-coated tablets. It was intended to be used for adults as add-on therapy for the treatment of pulmonary arterial hypertension (PAH).
The application for the marketing authorization for Ruvise was submitted to the European agency on 29 February 2012. At the time of the withdrawal, the medicine was under review by the agency's committee for Medicinal Products for Human Use (CHMP).
In its official letter, the company stated that it is withdrawing the application since additional data are required to address CHMP questions relating to the benefit-risk assessment of imatinib in PAH patients.