SITAGLIPTIN SANDOZ PHARMA (Sandoz Pty Ltd)
Product name
SITAGLIPTIN SANDOZ PHARMA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
148 (255 working days)
Active ingredients
sitagliptin hydrochloride monohydrate
Registration type
New generic medicine
Indication
SITAGLIPTIN SANDOZ PHARMA (film-coated tablet) is 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).