SITAGLIPTIN METFORMIN MAPLE (Maple Healthcare Pty Ltd)
Product name
SITAGLIPTIN METFORMIN MAPLE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
133 (175 working days)
Active ingredients
metformin hydrochloride, sitagliptin hydrochloride monohydrate
Registration type
New generic medicine
Indication
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].