Rybelsus (semaglutide)
- Region
- 🇪🇺 EU
- Active substance
- semaglutide
- Company
- Novo Nordisk A/S
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Fri 03 Apr 2020
- Application
- EMEA/H/C/004953
- ATC
- A10BJ06
- Official record
- www.ema.europa.eu
Indication
Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in combination with other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Wegovy Authorised · Novo Nordisk A/S
- 🇪🇺 Ozempic Authorised · Novo Nordisk A/S
- 🇪🇺 Kayshild Authorised · Novo Nordisk A/S
- 🇪🇺 Kyinsu Authorised · Novo Nordisk A/S
- 🇺🇸 Wegovy Approved · Novo
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.