OREANDA-NEWS. Merck, a leading science and technology company, today announced that the British Medicines and Healthcare products Regulatory Agency (MHRA), has approved on November 2 an updated labeling for Glucophage(r) XR (extended release metformin) for the treatment of patients with type 2 diabetes. The label change removes moderate renal impairment stage 3a and stable chronic heart failure from the list of the contraindications of Glucophage(r) XR.

Earlier in the year, the French regulatory authority Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM), had already approved an update of the labeling for Glucophage(r) IR (immediate release metformin) removing the same contraindications.

The label changes apply to all countries in the European Union. Glucophage(r) IR is approved by a Mutual Recognition Procedure, where France acted as the Reference Member State. In the case of Glucophage(r) XR the label changes were approved via a Worksharing Procedure in the European countries involved, where the UK was acting as the Reference Member State.