SOGROYA

This brand name is authorized in Austria, Croatia, Estonia, France, 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 more about Somapacitan

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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