Ngenla

RSS

somatrogon

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 06/12/2022

Authorisation details

Product details
Name
Ngenla
Agency product number
EMEA/H/C/005633
Active substance
somatrogon
International non-proprietary name (INN) or common name
somatrogon
Therapeutic area (MeSH)
Growth and Development
Anatomical therapeutic chemical (ATC) code
H01AC08
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
14/02/2022
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

05/12/2022 Ngenla - EMEA/H/C/005633 - IB/0007

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Therapeutic indication

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

Assessment history

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