ORGALUTRAN

This brand name is authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Estonia, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey.

Active ingredients

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

1	Ganirelix UNII IX503L9WN0 - GANIRELIX
	Ganirelix is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland. As a result a rapid, profound, reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by GnRH agonists.
	Read more about Ganirelix

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ORGALUTRAN 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
H01CC01	Ganirelix	H Systemic hormonal preparations, excl. Sex hormones and insulins → H01 Pituitary and hypothalamic hormones and analogues → H01C Hypothalamic hormones → H01CC Anti-gonadotropin-releasing hormones
Discover more medicines within H01CC01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	9583J, 9584K
BR	Câmara de Regulação do Mercado de Medicamentos	527302501154311
CA	Health Products and Food Branch	02245641
EE	Ravimiamet	1012059, 1064685
ES	Centro de información online de medicamentos de la AEMPS	00130001, 00130002
FR	Base de données publique des médicaments	62225235
HK	Department of Health Drug Office	49750
IL	מִשְׂרַד הַבְּרִיאוּת	4581
IT	Agenzia del Farmaco	034851016, 034851028
LT	Valstybinė vaistų kontrolės tarnyba	1010028, 1010029
NL	Z-Index G-Standaard	14649845
NL	Z-Index G-Standaard, PRK	59048
NZ	Medicines and Medical Devices Safety Authority	9366
PL	Rejestru Produktów Leczniczych	100102275
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67695001, W67695002
SG	Health Sciences Authority	12165P
TR	İlaç ve Tıbbi Cihaz Kurumu	8683280337312, 8683280337329
ZA	Health Products Regulatory Authority	46/21.10/0558