BLOOMS THE CHEMIST DAPAGLIFLOZIN (Sandoz Pty Ltd)
Product name
BLOOMS THE CHEMIST DAPAGLIFLOZIN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
118 (255 working days)
Active ingredients
dapagliflozin
Registration type
New generic medicine
Indication
Type 2 diabetes mellitus
Glycaemic control
TRADENAME is indicated in adults with type 2 diabetes mellitus:
- as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated.
- as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy (for example, high initial haemoglobin A1c [HbA1c] levels).
- in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see Section 5.1 Pharmacodynamic properties – Clinical trials and Section 4.4 Special warnings and precautions for use for available data on different add-on combination therapies).