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| Exchange Received Time 25/09/2019 18:00:05 Exchange Disseminated Time 25/09/2019 18:00:10 Time Taken 00:00:05 | This is to inform that AstraZeneca Pharma India Limited has received Import and Market permission in Form 45 (Marketing Authorization) from the Drugs Controller General of India for FDC of Dapagliflozin 10mg + Saxagliptin 5mg film coated tablets.
The receipt of this Import and Market permission paves way for the launch of FDC of Dapagliflozin 10mg + Saxagliptin 5mg film coated tablets (QTERN®) in India, subject to the receipt of other related statutory approvals and licenses.
FDC of Dapagliflozin 10mg + Saxagliptin 5mg is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus (T2DM).
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