RYBELSUS (Novo Nordisk Pharmaceuticals Pty Ltd)
Product name
RYBELSUS
Date registered
Evaluation commenced
Decision date
Approval time
203 (255 working days)
Active ingredients
semaglutide
Registration type
NCE/NBE
Indication
RYBELSUS (tablet) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
- as monotherapy if metformin is considered inappropriate due to intolerance or contraindications; or
- in combination with other medicinal products for the treatment of type 2 diabetes mellitus.