EMA — authorised 26 March 2026
- Application: EMEA/H/C/006426
- Marketing authorisation holder: Novo Nordisk A/S
- Local brand name: Kayshild
- 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).
- Pathway: conditional
- Status: approved
On 26 March 2026, the European Medicines Agency (EMA) granted a conditional marketing authorisation to Novo Nordisk A/S for Kayshild (semaglutide injectable product). Kayshild is indicated for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (fibrosis stages F2 to F3). This approval is based on an expedited conditional pathway.