Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: NGENLA
Active substances:
Somatrogon
Estonian, English, Latin
ATC code: H01AC08
Dosage form: solution for injection in pre-filled pen
Strength: 60mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
: 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: February 14, 2022 
Marketing authorization expires on: February 15, 2027 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1875911  NGENLA  solution for injection in pre-filled pen  60mg 1TK  Prescription  100%    03.04.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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