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RYBELSUS (Novo Nordisk Pharmaceuticals Pty Ltd)

Product name
RYBELSUS
Sponsor
Novo Nordisk Pharmaceuticals Pty Ltd
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.