GILENYA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States

Active ingredients

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

1 Fingolimod UNII G926EC510T - FINGOLIMOD HYDROCHLORIDE

Fingolimod is a sphingosine 1-phosphate receptor modulator. Fingolimod is metabolised by sphingosine kinase to the active metabolite fingolimod phosphate. By acting as a functional antagonist of S1P receptors on lymphocytes, fingolimod phosphate blocks the capacity of lymphocytes to egress from lymph nodes, causing a redistribution, rather than depletion, of lymphocytes. Read about Fingolimod

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
GILENYA Hard capsule	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
L04AE01	Fingolimod	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AE Sphingosine-1-phosphate (S1P) receptor modulators
Discover more medicines within L04AE01

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): 11818B, 5262Y
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 526532501115315
Country: CA	Health Products and Food Branch	Identifier(s): 02365480, 02482533
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): H4210413
Country: EE	Ravimiamet	Identifier(s): 1523720, 1523731, 1523742, 1665615, 1783492, 1783504
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 11677005
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 050438, 396371, 558770
Country: FR	Base de données publique des médicaments	Identifier(s): 60728597, 68003070
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 187411, 187412, 371435
Country: HK	Department of Health Drug Office	Identifier(s): 61192, 66472
Country: IE	Health Products Regulatory Authority	Identifier(s): 88407
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6713
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999029M1037
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1059635, 1059636, 1059637, 1059638, 1064021, 1073938, 1086816, 1086817
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 105M2011
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 100129, 196401
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 14612
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100244377, 100417688
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64461001, W64461002, W64461003, W64461004, W64461005, W66496001, W66496002
Country: SG	Health Sciences Authority	Identifier(s): 14153P, 15761P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 10283311H
Country: US	FDA, National Drug Code	Identifier(s): 0078-0607, 0078-0965