Posts Tagged ‘European Medicines Agency’

June 16th, 2014

European Regulators Investigate Cardiovascular Safety of Ibuprofen

The European Medicines Agency announced on Friday that it had initiated a review of the cardiovascular safety of ibuprofen when taken in high doses over an extended period of time. The review will be performed by the Pharmacovigilance Risk Assessment Committee (PRAC). The EMA said that people taking ibuprofen should continue to take it as long as they follow the […]

June 16th, 2014

European Medicines Agency Initiates Review of Ivabradine

There may be trouble on the horizon for ivabradine, a heart drug marketed by Servier under the brand names of Corlentor and Procoralan. The drug is widely available in Europe and elsewhere, though it is not available in the U.S., where it is under development by Amgen. Although it hasn’t been widely reported,  the European […]

November 29th, 2012

European Medicines Agency Destroys the Dam: Slight Dampness Results

Richard Lehman recounts an EMA data transparency workshop during which ideas for how to execute its new policy of allowing access to all data submitted for drug licensing were discussed.