SOGROYA

This brand name is authorized in Austria, Estonia, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, Romania

Active ingredients

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

1 Somapacitan UNII 8FOJ430U94 - SOMAPACITAN

Somapacitan is a long-acting recombinant human growth hormone derivative. The mechanism of action of somapacitan is either directly via the GH-receptor and/or indirectly via IGF-I produced in tissues throughout the body, but predominantly by the liver. When growth hormone deficiency is treated with somapacitan a normalisation of body composition (i.e., decreased body fat mass, increased lean body mass) and of metabolic action is achieved. Read about Somapacitan

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SOGROYA 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
H01AC07		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 H01AC07

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1846087, 1846098, 1882054
Country: FR	Base de données publique des médicaments	Identifier(s): 60043675, 60051647, 62039227
Country: IT	Agenzia del Farmaco	Identifier(s): 049439019, 049439021, 049439033, 049439045, 049439058, 049439060
Country: JP	医薬品医療機器総合機構	Identifier(s): 2412403G1020, 2412403G2026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1092401, 1092402
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100462156
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W67588001, W67588002, W69512001, W69512002