Is Dimethyl fumarate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 18 valid registrations of Dimethyl fumarate, including DEFRA 120MG DELAYED RELEASE CAPSULES (120 mg, Delayed-release capsule, SAR 404.45); DEFRA 240MG DELAYED RELEASE CAPSULES (240 mg, Delayed-release capsule, SAR 3235.90); Dimethyl Fumarate SPC (120 mg, Prolonged-release capsule, hard, SAR 780.00); Dimethyl Fumarate SPC (240 mg, Prolonged-release capsule, hard, SAR 1560.15); Fumadi (240 mg, Prolonged-release capsule, SAR 2912.30).

Is Dimethyl fumarate approved by the US FDA?

Drugs@FDA lists 18 application product lines for Dimethyl fumarate, including TECFIDERA (Prescription); DIMETHYL FUMARATE (Prescription); DIMETHYL FUMARATE (Prescription); DIMETHYL FUMARATE (Prescription); DIMETHYL FUMARATE (Prescription).

Is Dimethyl fumarate authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Dimethyl fumarate: Tecfidera, Skilarence, Dimethyl fumarate Mylan, Dimethyl fumarate Accord, Dimethyl fumarate Neuraxpharm.

Are there safety signals or safety updates for Dimethyl fumarate?

EMA PRAC: 4 entries; US FDA: 1 entry; MHRA: 3 entries (latest 2024-03-12).

Active substance

Dimethyl fumarate

SFDA 18
US FDA 18
EMA 11
Health Canada 10
US price lines 2
NHS prices 3
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DEFRA 120MG DELAYED RELEASE CAPSULES	120 mg	Delayed-release capsule · Oral use	14 Blister	SAR 404.45	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
DEFRA 240MG DELAYED RELEASE CAPSULES	240 mg	Delayed-release capsule · Oral use	56 Blister	SAR 3235.90	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Dimethyl Fumarate SPC	120 mg	Prolonged-release capsule, hard · Oral use	30 Blister	SAR 780.00	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Dimethyl Fumarate SPC	120 mg	Prolonged-release capsule, hard · Oral use	10 Blister	SAR 260.00	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Dimethyl Fumarate SPC	240 mg	Prolonged-release capsule, hard · Oral use	30 Blister	SAR 1560.15	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Dimethyl Fumarate SPC	240 mg	Prolonged-release capsule, hard · Oral use	10 Blister	SAR 520.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Fumadi	240 mg	Prolonged-release capsule · Oral use	60 Blister	SAR 2912.30	Generic · Prescription	ADEL AHMED AL-SHAEIR PHARMACEUTICAL COMPANY	Valid
Fumadi	120 mg	Prolonged-release capsule · Oral use	20 Blister	SAR 518.70	Generic · Prescription	ADEL AHMED AL-SHAEIR PHARMACEUTICAL COMPANY	Valid
Multifidera	240 mg	Capsule, hard · Oral use	60 Blister	SAR 2912.30	Generic · Prescription	Saudi Amarox	Valid
Multifidera	120 mg	Capsule, hard · Oral use	20 Blister	SAR 518.70	Generic · Prescription	Saudi Amarox	Valid
SCLERA 120 MG CAPSULE	120 mg	Gastro-resistant capsule, hard · Oral use	14 Blister	SAR 462.95	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
SCLERA 240 MG CAPSULE	240 mg	Gastro-resistant capsule, hard · Oral use	56 Blister	SAR 3703.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
TECFIDERA 120 mg capsule	120 mg	Capsule · Oral use	14 Blister	SAR 569.75	NCE · Prescription	Biogen Idec B.V-Natherland	Valid
TECFIDERA 240 mg capsule	240 mg	Capsule · Oral use	56 Blister	SAR 4558.15	NCE · Prescription	Biogen Idec B.V-Natherland	Valid
Tenipra	120 mg	Gastro-resistant capsule · Oral use	14 Blister	SAR 363.10	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Tenipra	240 mg	Gastro-resistant capsule · Oral use	56 Blister	SAR 2718.15	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Tredia	240 mg	Capsule, hard · Oral use	60 Bottle	SAR 2912.30	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Tredia	120 mg	Capsule, hard · Oral use	14 Bottle	SAR 364.00	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS; PSORIASIS

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

Product	Strength	Form · route	Applicant	Status	First approved
TECFIDERA	120MG; 240MG	capsule, delayed release · oral	BIOGEN	Prescription	27 Mar 2013
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	AMNEAL	Prescription	24 Sep 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	ALKEM LABS LTD	Prescription	24 Sep 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	MSN	Prescription	24 Sep 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	ACCORD HLTHCARE	Prescription	24 Sep 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	HETERO LABS LTD III	Prescription	24 Sep 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	LUPIN	Prescription	6 Oct 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	GLENMARK PHARMS LTD	Prescription	6 Oct 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	TWI PHARMS	Prescription	14 Oct 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	SOLA PHARMS	Prescription	26 Mar 2021
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	PRINSTON INC	Prescription	18 Oct 2022
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	AUROBINDO PHARMA	Prescription	22 Dec 2022
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	MACLEODS PHARMS	Prescription	26 Jun 2024
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	MYLAN	Discontinued	17 Aug 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	CIPLA	Discontinued	24 Sep 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	ZYDUS PHARMS	Discontinued	24 Sep 2020
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	SAWAI USA	Discontinued	21 Dec 2021
DIMETHYL FUMARATE	120MG; 240MG	capsule, delayed release · oral	TORRENT	Discontinued	6 Jan 2025

EMA European Union — centrally authorised medicines

Tecfidera Biogen Netherlands B.V. · Authorised · authorised 30 Jan 2014 · ATC L04AX07

Therapeutic indication (EMA)

Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Skilarence Almirall, S.A. · Authorised · authorised 23 Jun 2017 · ATC L04AX07

Therapeutic indication (EMA)

Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.

Dimethyl fumarate Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 22 Apr 2024 · ATC L04AX07

Therapeutic indication (EMA)

Dimethyl fumarate Mylan is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Dimethyl fumarate Accord Accord Healthcare Ltd · Authorised · authorised 22 Apr 2024 · ATC L04AX07

Therapeutic indication (EMA)

Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Dimethyl fumarate Neuraxpharm Neuraxpharm Pharmaceuticals S.L. · Authorised · authorised 22 Apr 2024 · ATC L04AX07

Therapeutic indication (EMA)

Dimethyl fumarate Neuraxpharm is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Dimherity Sandoz GmbH · Application withdrawn

Therapeutic indication (EMA)

Treatment of multiple sclerosis.

Dimethyl fumarate Polpharma Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. · Revoked · authorised 13 May 2022 · ATC L04AX07

Therapeutic indication (EMA)

Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Dimethyl fumarate Mylan Mylan Ireland Limited · Revoked · authorised 13 May 2022 · ATC L04AX07

Therapeutic indication (EMA)

Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Dimethyl fumarate Neuraxpharm Laboratorios Lesvi S.L. · Revoked · authorised 13 May 2022 · ATC L04AX07

Therapeutic indication (EMA)

Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Dimethyl fumarate Teva Teva GmbH · Revoked · authorised 12 Dec 2022 · ATC L04AX07

Therapeutic indication (EMA)

Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Dimethyl fumarate Accord Accord Healthcare S.L.U. · Revoked · authorised 15 Feb 2023 · ATC L04AX07

Therapeutic indication (EMA)

Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-DIMETHYL FUMARATE	02505762	120 MG	CAPSULE (DELAYED-RELEASE) · ORAL	APOTEX INC
APO-DIMETHYL FUMARATE	02505770	240 MG	CAPSULE (DELAYED-RELEASE) · ORAL	APOTEX INC
AURO-DIMETHYL FUMARATE	02540746	120 MG	CAPSULE (DELAYED-RELEASE) · ORAL	AURO PHARMA INC
AURO-DIMETHYL FUMARATE	02540754	240 MG	CAPSULE (DELAYED-RELEASE) · ORAL	AURO PHARMA INC
JAMP DIMETHYL FUMARATE	02516047	120 MG	CAPSULE (DELAYED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
JAMP DIMETHYL FUMARATE	02516055	240 MG	CAPSULE (DELAYED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
PMS-DIMETHYL FUMARATE	02497026	120 MG	CAPSULE (DELAYED-RELEASE) · ORAL	PHARMASCIENCE INC
PMS-DIMETHYL FUMARATE	02497034	240 MG	CAPSULE (DELAYED-RELEASE) · ORAL	PHARMASCIENCE INC
TECFIDERA	02404508	120 MG	CAPSULE (DELAYED-RELEASE) · ORAL	BIOGEN CANADA INC
TECFIDERA	02420201	240 MG	CAPSULE (DELAYED-RELEASE) · ORAL	BIOGEN CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DIMETHYL FUMARATE DR 120 MG CP	$0.42839	per EA	23 Sep 2026
US NADAC	DIMETHYL FUMARATE DR 240 MG CP	$0.46717	per EA	23 Sep 2026
NHS Drug Tariff	Dimethyl fumarate 120mg gastro-resistant tablets	£190.80	90 tablet	1 Oct 2026
NHS Drug Tariff	Dimethyl fumarate 120mg gastro-resistant tablets	£381.60	180 tablet	1 Oct 2026
NHS Drug Tariff	Dimethyl fumarate 30mg gastro-resistant tablets	£89.04	42 tablet	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 12 Mar 2024 TECFIDERA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 7 Jan 2021 Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia
The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy (PML) in patients with mild lymphopenia. Continue to monitor lymphocyte counts and advise patients to seek urgent medical attention if they experience any symptoms or signs suggestive of PML.
EMA PRAC 17 Jan 2019 PRAC signal: Arthritis and arthralgia
Action for MAH: update of the product information: No
EMA PRAC 6 Sep 2018 PRAC signal: Immune thrombocytopenic purpura and thrombocytopenia
Action for MAH: update of the product information: Yes
EMA PRAC 12 Apr 2018 PRAC signal: Immune thrombocytopenic purpura and thrombocytopenia
Action for MAH: update of the product information: No
MHRA 18 Apr 2016 Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy
Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.
MHRA 30 Mar 2015 Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia
Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy.
EMA PRAC 6 Nov 2014 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: Yes

All safety entries for dimethyl fumarate →

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.