JANUVIA, XELEVIA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
JANUVIA, XELEVIA
Date registered
Evaluation commenced
Decision date
Approval time
150 working days (255)
Active ingredients
sitagliptin phosphate monohydrate
Registration type
EOI
Indication
JANUVIA, XELEVIA (film coated tablet) are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:
- monotherapy when metformin is considered inappropriate due to intolerance; or
- in combination with other anti-hyperglycaemic agents, including insulin.
[see Sections 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, and 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on different add-on combination therapies].