SITAGLIPTIN/METFORMIN XR KND (Maple Healthcare Pty Ltd)
Product name
SITAGLIPTIN/METFORMIN XR KND
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
132 (255 working days)
Active ingredients
metformin hydrochloride, sitagliptin phosphate
Registration type
New generic medicine
Indication
SITAGLIPTIN/METFORMIN (sitagliptin phosphate and metformin hydrochloride) is 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 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION].