Ozempic (semaglutide)
- Region
- 🇪🇺 EU
- Active substance
- semaglutide
- Company
- Novo Nordisk A/S
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus
- CHMP opinion
- Thu 09 Nov 2017
- EU approval
- Thu 08 Feb 2018
- Application
- EMEA/H/C/004174
- ATC
- A10BJ06
- Official record
- www.ema.europa.eu
Indication
Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in addition to 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
- 🇪🇺 Kayshild Authorised · Novo Nordisk A/S
- 🇪🇺 Rybelsus 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.