EMA — authorised 14 February 2022
- Marketing authorisation holder: PFIZER EUROPE MA EEIG
- Status: approved
🇪🇺 Ngenla in European Union
EMA authorised Ngenla on 14 February 2022
Marketing authorisations
EMA — authorised 14 February 2022
- Application: EMEA/H/C/005633
- Marketing authorisation holder: Pfizer Europe MA EEIG
- Local brand name: Ngenla
- Indication: Indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone
- Pathway: orphan
- Status: approved
Ngenla 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 Ngenla approved in European Union?
Yes. EMA authorised it on 14 February 2022; EMA authorised it on 14 February 2022.
Who is the marketing authorisation holder for Ngenla in European Union?
PFIZER EUROPE MA EEIG holds the EU marketing authorisation.