SITAGLIPTIN/METFORMIN SANDOZ XR (Sandoz Pty Ltd)
Product name
SITAGLIPTIN/METFORMIN SANDOZ XR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
119 (255 working days)
Active ingredients
metformin hydrochloride, sitagliptin hydrochloride monohydrate
Registration type
New generic medicine
Indication
Sitagliptin/Metformin Sandoz XR (sitagliptin (as hydrochloride monohydrate) 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 Section 5.1 Pharmacodynamic properties, Clinical trials and 4.2 Dose and method of administration].