LINAGLIPTIN VIATRIS (Alphapharm Pty Ltd)
Product name
LINAGLIPTIN VIATRIS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
116 (255 working days)
Active ingredients
linagliptin
Registration type
New generic medicine
Indication
LINAGLIPTIN VIATRIS is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in conjunction with diet and exercise, as monotherapy when metformin and sulfonylureas are not tolerated, or are contraindicated, or as add on to metformin, sulfonylureas or metformin plus sulfonylureas, or to insulin (with or without metformin) or as add on to metformin plus SGLT2 inhibitors.