ORGALUTRAN

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

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 about Ganirelix

Medication package inserts

Below package inserts are available for further reading:

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