Almitrine-containing medicines regulatory update

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended that all marketing authorizations for oral almitrine-containing medicines be withdrawn across the EU after concluding that their benefits no longer outweigh their risks. EMA said almitrine has been approved since 1982 in some EU countries for chronic respiratory failure associated with chronic obstructive pulmonary disease (COPD). Servier (Neuilly-sur-Seine, France) markets almitrine in France and Portugal as Vectarion and in Poland as Armanor. EMA's Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) will now consider the PRAC recommendation. ...