SIDAPVIA (AstraZeneca Pty Ltd)
Product name
SIDAPVIA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
224 (255 working days)
Active ingredients
dapagliflozin propanediol monohydrate, sitagliptin phosphate monohydrate
Registration type
New combination
Indication
SIDAPVIA is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and sitagliptin is appropriate. (See sections 4.5 Interactions with other medicines and other forms of interactions and 5.1 Pharmacodynamic properties – Clinical trials.)
SIDAPVIA should be used in combination with metformin unless contraindicated or not tolerated.