JARDIANCE (Boehringer Ingelheim Pty Ltd)
Product name
JARDIANCE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
211 (255 working days)
Active ingredients
empagliflozin
Registration type
EOI
Indication
Heart failure
JARDIANCE is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see Section 5.1 Pharmacodynamic properties - Clinical trials).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine