
Metformin + Dapagliflozin Tablets
Form: Tablets
Strength: (dapagliflozin/metformin): 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, 10 mg/1000 mg
Reference Brands: Xigduo XR®(US and EU)
Category: Diabetes
In the US, dapagliflozin/metformin (Xigduo XR) was approved by the FDA in February 2014 for type 2 diabetes as an adjunct to diet and exercise, with a warning to stop temporarily before surgery to reduce ketoacidosis risk. In the EU, Xigduo received marketing authorization in January 2014, and Ebymect in November 2015, for glycemic control in adults when metformin alone is inadequate. The EMA expanded metformin use in 2016 to patients with moderate kidney impairment (GFR 30–59 ml/min), with dose adjustments and monitoring for lactic acidosis. For sourcing, check Pharmatradz.com for supplier details and availability
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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