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XULTOPHY (Novo Nordisk Pharmaceuticals Pty Ltd)
Product name
XULTOPHY
Date registered
Evaluation commenced
Decision date
Approval time
186 working days (225)
Active ingredients
insulin degludec; liraglutide
Registration type
EOI
Indication
New Combination
XULTROPHY (solution for injection) is indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with metformin, with or without other oral glucose-lowering medicinal products (see Section 5.1 Pharmacodynamic Properties-Clinical trials and Section 4.4 Special Warnings and Precautions for Use' for available data on the different combinations).