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SITAGLIPTIN/METFORMIN (Sun Pharma ANZ Pty Ltd)
Product name
SITAGLIPTIN/METFORMIN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
130 (255 working days)
Active ingredients
sitagliptin fumarate, metformin hydrochloride
Registration type
New generic medicine
Indication
SITAGLIPTIN/METFORMIN SUN (sitagliptin fumarate and metformin hydrochloride) are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. [see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION].