Novartis Europharm Ltd withdraws marketing authorisation application for Ruvise (imatinib mesilate) for treatment of pulmonary arterial hypertension

Source: Eur Meds Agency Area: News The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for centralised marketing authorisation of Ruvise (imatinib mesilate) tablets, intended to be used for adults as add-on therapy for the treatment of pulmonary arterial hypertension (PAH). The company stated that it is withdrawing the application since additional data are required to address questions relating to the benefit-risk assessment of imatinib in PAH patients. These data will not be available within the timeframe allowed in the centralised procedure.
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news