Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
NGENLA
|
Active substances:
|
|
ATC code:
|
H01AC08
|
Dosage form:
|
solution for injection in pre-filled pen
|
Strength:
|
24mg
|
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
|
1875900
|
NGENLA
|
solution for injection in pre-filled pen
|
24mg 1TK
|
Prescription
|
100%
|
|
15.11.2023
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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