Merck's Glucophage(r) XR Can be Used for More Type 2 Diabetes Patients
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.
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