Product class: Authorized package
Medicinal product class: For human use
Package code: 1875900
Name of medicinal product: NGENLA
Active substances:
Somatrogon
Estonian, English, Latin
ATC code: H01AC08
Dosage form: solution for injection in pre-filled pen
Route of administration: subcutaneous use
Strengh: 24mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Ngenla is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: 15 November 2023
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Pfizer Europe MA EEIG 
Marketing authorization number: EU/1/21/1617 
Marketing authorization issued on: 14 February 2022 
Marketing authorization expires on: 15 February 2027 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05/04/2024     Yes  E23-E23; E89.3-E89.3  Endokrinoloog, Pediaater – endokrinoloog  No     kuni kasvutsoonide sulgumiseni 
100  05/04/2024     Yes  E23-E23; E89.3-E89.3  Pediaater – endokrinoloog, Endokrinoloog  No  until 4 years  kuni kasvutsoonide sulgumiseni 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 01 March 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription