Ngenla
somatrogon
Table of contents
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.
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List item
Ngenla : EPAR - Medicine Overview (PDF/122.33 KB)
First published: 02/03/2022
EMA/5527/2022 -
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Ngenla : EPAR - Risk management plan summary (PDF/122.9 KB)
First published: 02/03/2022
Authorisation details
Product details | |
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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 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. |
Orphan |
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 | |
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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 |
Product information
05/12/2022 Ngenla - EMEA/H/C/005633 - IB/0007
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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