Is Fingolimod registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 12 valid registrations of Fingolimod, including Eligon (0.5 mg, Capsule, hard, SAR 3225.30); FEGONA 0.5 MG CAPSULE (0.5 mg, Capsule, SAR 4806.25); Figoya (0.5 mg, Capsule, hard, SAR 3010.30); GILENYA 0.5 MG CAPSULE (0.5 mg, Capsule, SAR 5915.40); Gemorya (0.5 mg, Capsule, SAR 3010.30).

Is Fingolimod approved by the US FDA?

Drugs@FDA lists 20 application product lines for Fingolimod, including GILENYA (Prescription); FINGOLIMOD HYDROCHLORIDE (Prescription); FINGOLIMOD HYDROCHLORIDE (Prescription); FINGOLIMOD HYDROCHLORIDE (Prescription); FINGOLIMOD HYDROCHLORIDE (Prescription).

Is Fingolimod authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Fingolimod: Gilenya, Fingolimod Accord, Fingolimod Mylan.

Are there safety signals or safety updates for Fingolimod?

EMA PRAC: 6 entries; US FDA: 1 entry; MHRA: 7 entries (latest 2025-08-22).

Active substance

Fingolimod

SFDA 12
US FDA 20
EMA 4
Health Canada 7
US price lines 1
NHS prices 1
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Eligon	0.5 mg	Capsule, hard · Oral use	30 Blister	SAR 3225.30	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
FEGONA 0.5 MG CAPSULE	0.5 mg	Capsule · Oral use	28 Blister	SAR 4806.25	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Figoya	0.5 mg	Capsule, hard · Oral use	28 Blister	SAR 3010.30	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
GILENYA 0.5 MG CAPSULE	0.5 mg	Capsule · Oral use	28 Blister	SAR 5915.40	NCE · Prescription	NOVARTIS	Valid
Gemorya	0.5 mg	Capsule · Oral use	28 Blister	SAR 3010.30	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Gemorya	0.25 mg	Capsule · Oral use	28 Blister	SAR 1505.15	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Golifa	0.5 mg	Capsule, hard · Oral use	28 Blister	SAR 3010.30	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Golimara	0.5 mg	Capsule, hard · Oral use	28 Blister	SAR 4436.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Keroz	0.5 mg	Capsule, hard · Oral use	28 Blister	SAR 3225.30	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
OLICAN	0.5 mg	Capsule · Oral use	28 Blister	SAR 3583.65	Generic · Prescription	PHARMASCIENCE INC.	Valid
OLYMA	0.5 mg	Capsule · Oral use	28 Bottle	SAR 3010.00	Generic · Prescription	Med City Pharma	Valid
Sphingolin	0.5 mg	Capsule, hard · Oral use	60 Blister	SAR 4450.40	Generic · Prescription	Saudi Amarox	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
GILENYA	EQ 0.5MG BASE; EQ 0.25MG BASE	capsule · oral	NOVARTIS	Prescription	21 Sep 2010
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	BIOCON LTD	Prescription	4 Dec 2019
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	HETERO LABS LTD V	Prescription	18 May 2020
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	GLENMARK PHARMS LTD	Prescription	18 Jun 2020
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	TEVA PHARMS USA	Prescription	2 Jul 2020
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	ZYDUS PHARMS	Prescription	14 Oct 2020
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	ACCORD HLTHCARE	Prescription	28 Oct 2020
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	APOTEX	Prescription	18 Dec 2020
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	ALKEM LABS LTD	Prescription	30 Dec 2020
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	DR REDDYS	Prescription	5 Mar 2021
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	HEC PHARM CO LTD	Prescription	10 Nov 2021
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	PRINSTON INC	Prescription	7 Sep 2022
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	BIONPHARMA	Prescription	24 May 2023
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	EZRA VENTURES	Prescription	6 Dec 2023
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	AUROBINDO PHARMA LTD	Prescription	28 Feb 2024
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	ALEMBIC	Prescription	24 Apr 2026
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	SUN PHARM	Discontinued	4 Dec 2019
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	CHARTWELL RX	Discontinued	29 Jun 2020
FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	capsule · oral	MYLAN	Discontinued	19 Jan 2021
FINGOLIMOD HYDROCHLORIDE	EQ 0.25MG BASE	capsule · oral	TEVA PHARMS USA	Discontinued	12 Nov 2021

EMA European Union — centrally authorised medicines

Gilenya Novartis Europharm Limited · Authorised · authorised 17 Mar 2011 · ATC L04AE01

Therapeutic indication (EMA)

Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1). or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Fingolimod Accord Accord Healthcare S.L.U. · Authorised · authorised 25 Jun 2020 · ATC L04AA27

Therapeutic indication (EMA)

Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Fingolimod Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 18 Aug 2021 · ATC L04AE01

Therapeutic indication (EMA)

Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Fingolimod Mylan Mylan Ireland Limited · Application withdrawn · authorised 18 Aug 2021 · ATC L04AA27

Therapeutic indication (EMA)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
GILENYA	02365480	0.5 MG	CAPSULE · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
GILENYA	02482533	0.25 MG	CAPSULE · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
JAMP FINGOLIMOD	02487772	0.5 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
MYLAN-FINGOLIMOD	02469715	0.5 MG	CAPSULE · ORAL	MYLAN PHARMACEUTICALS ULC
PMS-FINGOLIMOD	02469782	0.5 MG	CAPSULE · ORAL	PHARMASCIENCE INC
SANDOZ FINGOLIMOD	02482606	0.5 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
TARO-FINGOLIMOD	02469618	0.5 MG	CAPSULE · ORAL	TARO PHARMACEUTICALS INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FINGOLIMOD 0.5 MG CAPSULE	$1.57913	per EA	23 Sep 2026
NHS Drug Tariff	Fingolimod 500microgram capsules	£1470.00	28 capsule	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 22 Aug 2025 GILENYA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 7 Jan 2021 Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis
Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster viruses have also been reported during treatment. Advise patients to seek urgent medical attention if they develop any clinical features of liver dysfunction or meningoencephalitis. Discontinue fingolimod if significant hepatic injury or herpes meningoencephalitis is confirmed.
MHRA 19 Sep 2019 Fingolimod (Gilenya▼): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception
Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraception during fingolimod treatment and for 2 months after discontinuation.
EMA PRAC 6 Sep 2018 PRAC signal: Autoimmune haemolytic anaemia
Action for MAH: update of the product information: No
MHRA 14 Dec 2017 Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.
MHRA 14 Dec 2017 Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
Monitor patients closely for skin cancers. Advise patients to seek urgent attention if they develop signs or symptoms of serious infections.
MHRA 18 Apr 2016 Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
EMA PRAC 7 May 2015 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: Yes
EMA PRAC 12 Mar 2015 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Fingolimod (Gilenya▼): bradycardia and heart block
Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
MHRA 11 Dec 2014 Fingolimod (Gilenya▼): not recommended for patients at known risk of cardiovascular adverse events
New advice for extended early monitoring for those with significant bradycardia or heart block after first dose.
EMA PRAC 5 Sep 2013 PRAC signal: Spontaneous abortion and blighted ovum
Action for MAH: update of the product information: No
EMA PRAC 11 Apr 2013 PRAC signal: Haemophagocytic syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 31 Oct 2012 PRAC signal: Haemophagocytic syndrome
Action for MAH: update of the product information: No

All safety entries for fingolimod →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.