BioCentury
ARTICLE | Clinical News

Almitrine-containing medicines regulatory update

June 10, 2013 7:00 AM UTC

EMA's Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) endorsed a recommendation from the agency's Pharmacovigilance Risk Assessment Committee (PRAC) to suspend marketing authorization of oral almitrine-containing medicines in the EU. EMA said almitrine has been approved since 1982 in some EU countries for chronic respiratory failure associated with chronic obstructive pulmonary disease (COPD). The EU member states will implement the marketing withdrawals. Servier (Neuilly-sur-Seine, France) markets almitrine in France and Portugal as Vectarion and in Poland as Armanor. ...