NGENLA

This brand name is authorized in Canada, Estonia, Croatia, Italy, Japan, Poland, Romania, Turkey

Active ingredients

The drug NGENLA contains one active pharmaceutical ingredient (API):

1 Somatrogon UNII 6D848RA61B - SOMATROGON

Somatrogon is a glycoprotein comprised of the amino acid sequence of hGH with one copy of the of C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of somatrogon, which allows for weekly dosing. Somatrogon binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Read about Somatrogon

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
NGENLA Solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
H01AC08		H Systemic hormonal preparations, excl. Sex hormones and insulins → H01 Pituitary and hypothalamic hormones and analogues → H01A Anterior pituitary lobe hormones and analogues → H01AC Somatropin and somatropin agonists
Discover more medicines within H01AC08

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02521679, 02521687
Country: EE	Ravimiamet	Identifier(s): 1875900, 1875911
Country: IT	Agenzia del Farmaco	Identifier(s): 049913015, 049913027
Country: JP	医薬品医療機器総合機構	Identifier(s): 2412404G1024, 2412404G2020
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100465918, 100465925
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68503001, W68504001
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8681308951007, 8681308951106