Kayshild (semaglutide)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- semaglutide
- Company
- Novo Nordisk A/S
- Status
- Authorised
- Therapeutic area
- Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
- CHMP opinion
- Thu 29 Jan 2026
- EU approval
- Thu 26 Mar 2026
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/006426
- ATC
- A10BJ06
- Official record
- www.ema.europa.eu
Indication
Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
Regulatory milestones
Thu 26 Mar 2026🇪🇺 EU approval (EC decision)
Kayshild (semaglutide) approved in the EU
Marketing authorisation to Novo Nordisk A/S; Conditional, Additional monitoring · source
Thu 29 Jan 2026🇪🇺 CHMP positive opinion
Kayshild (semaglutide): CHMP positive opinion
Novo Nordisk A/S; Conditional, Additional monitoring · source
Same substance in other markets
- 🇪🇺 Wegovy Authorised · Novo Nordisk A/S
- 🇪🇺 Ozempic 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.