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EMA Product

Ngenla

Product approved by European Medicines Agency (EU)

Basic Information

Ngenla

Regulatory Information

EMEA/H/C/005633

Authorised

February 14, 2022

December 16, 2021

5

December 5, 2022

Company Information

Belgium

Boulevard de la Plaine 17 1050 Bruxelles

Pfizer Europe MA EEIG

Drug Classification

Orphan MedicineAdditional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone

Overview Summary

Ngenla is a medicine used to treat children and adolescents who are not growing at the normal rate as a result of growth hormone deficiency (lack of natural growth hormone). It is given to patients from 3 years of age. Ngenla contains the active substance somatrogon.

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