From Drugs Controller General of India
AstraZeneca Pharma India has received Import and Market permission in Form CT-20 (Marketing Authorization- Additional Indication) from the Drugs Controller General of India for Dapagliflozin film coated tablet 10mg.Dapagliflozin film coated tablet 10mg is additional indication in adults for the treatment of heart failure with reduced ejection fraction.
The receipt of this Import and Market permission paves way for launch of Dapagliflozin film coated tablet 10mg in India, subject to the receipt of related statutory approvals and licenses.
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