Ngenla (somatrogon)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- somatrogon
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Growth and Development
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Mon 14 Feb 2022
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005633
- ATC
- H01AC08
- Official record
- www.ema.europa.eu
Indication
Indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone
Regulatory milestones
No milestones recorded in the last year.
Follow Ngenla
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.