Is Teriflunomide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Teriflunomide, including AUBAGIO 14 mg film-coated tablet (14 mg, Film-coated tablet, SAR 2715.60); Aubomide (14 mg, Film-coated tablet, SAR 1258.20); Axyla (14 mg, Film-coated tablet, SAR 2534.55); BAUDA (14 mg, Film-coated tablet, SAR 1258.20); Myteb (14 mg, Film-coated tablet, SAR 2172.50).

Is Teriflunomide approved by the US FDA?

Drugs@FDA lists 20 application product lines for Teriflunomide, including AUBAGIO (Prescription); TERIFLUNOMIDE (Prescription); TERIFLUNOMIDE (Prescription); TERIFLUNOMIDE (Prescription); TERIFLUNOMIDE (Prescription).

Is Teriflunomide authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Teriflunomide: Aubagio, Teriflunomide Accord, Teriflunomide Viatris (previously Teriflunomide Mylan).

Are there safety signals or safety updates for Teriflunomide?

EMA PRAC: 7 entries; US FDA: 1 entry (latest 2026-02-11).

Active substance

Teriflunomide

SFDA 8
US FDA 20
EMA 3
Health Canada 7
US price lines 2
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
AUBAGIO 14 mg film-coated tablet	14 mg	Film-coated tablet · Oral use	28 Blister	SAR 2715.60	NCE · Prescription	Sanofi B.V	Valid
Aubomide	14 mg	Film-coated tablet · Oral use	28 Blister	SAR 1258.20	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Axyla	14 mg	Film-coated tablet · Oral use	28 Blister	SAR 2534.55	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
BAUDA	14 mg	Film-coated tablet · Oral use	28 Blister	SAR 1258.20	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Myteb	14 mg	Film-coated tablet · Oral use	28 Blister	SAR 2172.50	Generic · Prescription	Med City Pharma	Valid
Teralas	14 mg	Film-coated tablet · Oral use	28 Blister	SAR 2172.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Teriflunomide BOS	14 mg	Film-coated tablet · Oral use	30 Blister	SAR 1765.10	Generic · Prescription	Boston Oncology Arabia	Valid
Trovapt	14 mg	Tablet · Oral use	28 Blister	SAR 2172.50	Generic · Prescription	Apotex Inc	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
AUBAGIO	7MG; 14MG	tablet · oral	SANOFI AVENTIS US	Prescription	12 Sep 2012
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	TEVA PHARMS USA	Prescription	4 Sep 2018
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	AUROBINDO PHARMA	Prescription	26 Oct 2018
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	GLENMARK SPECLT	Prescription	15 Nov 2018
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	ZYDUS PHARMS	Prescription	30 Nov 2018
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	SANDOZ	Prescription	3 Jan 2019
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	ACCORD HLTHCARE	Prescription	7 Jan 2019
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	ALEMBIC	Prescription	19 Apr 2019
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	MSN	Prescription	24 Apr 2019
TERIFLUNOMIDE	14MG; 7MG	tablet · oral	SOLA PHARMS	Prescription	17 Jun 2020
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	HETERO LABS LTD V	Prescription	13 Mar 2023
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	BIOCON PHARMA	Prescription	13 Mar 2023
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	NATCO	Prescription	15 May 2023
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	NEOCUBES PHARMA	Prescription	7 Apr 2025
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	WATSON LABS TEVA	Discontinued	27 Jul 2018
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	AMNEAL PHARMS CO	Discontinued	28 Sep 2018
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	APOTEX	Discontinued	2 Nov 2018
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	SOMERSET THERAPS LLC	Discontinued	28 Feb 2020
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	BRECKENRIDGE	Discontinued	24 Sep 2021
TERIFLUNOMIDE	7MG; 14MG	tablet · oral	TORRENT	Discontinued	4 Apr 2024

EMA European Union — centrally authorised medicines

Aubagio Sanofi Winthrop Industrie · Authorised · authorised 26 Aug 2013 · ATC L04AK02

Therapeutic indication (EMA)

AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).

Teriflunomide Accord Accord Healthcare S.L.U. · Authorised · authorised 9 Nov 2022 · ATC L04AK02

Therapeutic indication (EMA)

Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).

Teriflunomide Viatris (previously Teriflunomide Mylan) Viatris Limited · Authorised · authorised 9 Nov 2022 · ATC L04AK02

Therapeutic indication (EMA)

Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-TERIFLUNOMIDE	02500639	14 MG	TABLET · ORAL	APOTEX INC
JAMP TERIFLUNOMIDE	02504170	14 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-TERIFLUNOMIDE	02523833	14 MG	TABLET · ORAL	MANTRA PHARMA INC
NAT-TERIFLUNOMIDE	02500310	14 MG	TABLET · ORAL	NATCO PHARMA (CANADA) INC
PMS-TERIFLUNOMIDE	02500434	14 MG	TABLET · ORAL	PHARMASCIENCE INC
SANDOZ TERIFLUNOMIDE	02505843	14 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TEVA-TERIFLUNOMIDE	02501090	14 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TERIFLUNOMIDE 14 MG TABLET	$0.23335	per EA	23 Sep 2026
US NADAC	TERIFLUNOMIDE 7 MG TABLET	$0.29186	per EA	23 Sep 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 11 Feb 2026 AUBAGIO — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 5 Sep 2019 PRAC signal: Psoriasis
Action for MAH: update of the product information: Yes
EMA PRAC 11 Apr 2019 PRAC signal: Psoriasis
Action for MAH: update of the product information: No
EMA PRAC 4 Oct 2018 PRAC signal: Dyslipidaemia
Action for MAH: update of the product information: Yes
EMA PRAC 17 May 2018 PRAC signal: Dyslipidaemia
Action for MAH: update of the product information: No
EMA PRAC 29 Sep 2017 PRAC signal: Lymphoma
Action for MAH: update of the product information: No
EMA PRAC 6 Apr 2017 PRAC signal: Falsely decreased ionised calcium levels
Action for MAH: update of the product information: Yes
EMA PRAC 1 Dec 2016 PRAC signal: Falsely decreased ionised calcium levels
Action for MAH: update of the product information: No

All safety entries for teriflunomide →

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.