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APO-VILDAGLIPTIN/METFORMIN (Arrotex Pharmaceuticals Pty Ltd)

Product name
APO-VILDAGLIPTIN/METFORMIN
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
metformin hydrochloride, vildagliptin
Registration type
New generic medicine
Indication

[TRADE NAME] is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. Treatment should not be initiated with this fixed-dose combination.

[TRADE NAME] is indicated in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea.

[TRADE NAME] is indicated as add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.