EMA — authorised 11 January 2022
- Marketing authorisation holder: ASCENDIS PHARMA ENDOCRINOLOGY DIVISION A/S
- Status: approved
🇪🇺 Skytrofa in European Union
EMA authorised Skytrofa on 11 January 2022
Marketing authorisations
EMA — authorised 11 January 2022
- Application: EMEA/H/C/005367
- Marketing authorisation holder: Ascendis Pharma Endocrinology Division A/S
- Local brand name: Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
- Indication: Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD])
- Pathway: orphan
- Status: approved
Skytrofa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Skytrofa approved in European Union?
Yes. EMA authorised it on 11 January 2022; EMA authorised it on 11 January 2022.
Who is the marketing authorisation holder for Skytrofa in European Union?
ASCENDIS PHARMA ENDOCRINOLOGY DIVISION A/S holds the EU marketing authorisation.