GILENYA

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

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 more about Fingolimod

Medication package inserts

Below package inserts are available for further reading:

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