Press Release: Oral almitrine to be withdrawn by EU Member States

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a medicines regulatory body representing the EU Member States, in May 2013, endorsed the recommendation by the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), that permission to market oral medicines containing almitrine should be withdrawn across the European Union.

Almitrine is authorised in France, Poland and Portugal to be taken orally for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood). These conditions pose a particular problem in patients with lung conditions known as chronic obstructive pulmonary disease (COPD), where the airways and air sacs inside the lungs become damaged or blocked.

EMA: Press Release: EMA/313994/2013 (29.05.13): Oral almitrine to be withdrawn by EU Member States http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2013/05/WC500143801.pdf

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