Product Dossier
RYBELSUS
Product Dossier for RYBELSUS (Semaglutide, Novo Nordisk Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Novo Nordisk Pharmaceuticals
- Active ingredient: Semaglutide
- Therapeutic area: Endocrinology
- Related brand: OZEMPIC
- Related brand: WEGOVY
- Related brand: PLOSBRIO
- Same area: JANUMET
- Same area: LEVOXINE
What it is
Rybelsus 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. Rybelsus is an oral formulation of semaglutide that stimulates insulin and lowers glucagon.
Approved indications
— 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 — Treatment of adults with insufficiently controlled type 2 diabetes mellitus in combination with other medicinal products for the treatment of type 2 diabetes mellitus
Regulatory history
The TGA approved Rybelsus (semaglutide) 3 mg, 7 mg, and 14 mg tablets for the treatment of adults with insufficiently controlled type 2 diabetes mellitus. The 3 mg, 7 mg, and 14 mg tablet formulations were first listed on the ARTG on 7 February 2022. This decision aligns with approvals in other major international regions.