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JANUMET HCI, JANUMET XR, VELMETIA, VELMETIA XR (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
JANUMET HCI, JANUMET XR, VELMETIA, VELMETIA XR
Date registered
Evaluation commenced
Decision date
Approval time
150 working days (255)
Active ingredients
sitagliptin phosphate monohydrate; metformin hydrochloride
Registration type
EOI
Indication
JANUMET, JANUMET XR, VELMETIA, VELMETIA XR (film coated tablet, extended release tablet, modified release tablet) 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 Sections 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION]