Is Cladribine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Cladribine, including Cladribine Atnahs (1 mg/ml, Concentrate for solution for infusion, SAR 1388.60); Clodreb (10 mg, Tablet, SAR 40050.10); MAVENCLAD (10 mg, Tablet, SAR 7485.10).

Is Cladribine approved by the US FDA?

Drugs@FDA lists 8 application product lines for Cladribine, including CLADRIBINE (Prescription); CLADRIBINE (Prescription); MAVENCLAD (Prescription); CLADRIBINE (Prescription); CLADRIBINE (Prescription).

Is Cladribine authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Cladribine: Litak, Mavenclad.

Is Cladribine on the WHO Model List of Essential Medicines?

Yes — 5.1.2. Medicines for multiple sclerosis (complementary list): Multiple sclerosis.

Are there safety signals or safety updates for Cladribine?

EMA PRAC: 3 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2026-05-14).

Active substance

Cladribine

SFDA 5
US FDA 8
EMA 3
Health Canada 5
WHO EML 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Cladribine Atnahs	1 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1388.60	NCE · Prescription	Atnahs Pharma UK Limited	Valid
Clodreb	10 mg	Tablet · Oral use	6 Blister	SAR 40050.10	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Clodreb	10 mg	Tablet · Oral use	4 Blister	SAR 26700.05	Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Clodreb	10 mg	Tablet · Oral use	1 Blister	SAR 6675.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
MAVENCLAD	10 mg	Tablet · Oral use	1 Blister	SAR 7485.10	NCE · Prescription	Merck Europe BV	Valid

Indications — CHI Daman Drug Formulary

LYMPHOPLASMACYTIC LYMPHOMA; MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
CLADRIBINE	1MG/ML	injectable · injection	HIKMA PHARMS	Prescription	28 Feb 2000
CLADRIBINE	1MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	22 Apr 2004
MAVENCLAD	10MG	tablet · oral	EMD SERONO INC	Prescription	29 Mar 2019
CLADRIBINE	1MG/ML	injectable · injection	HISUN PHARM HANGZHOU	Prescription	25 Nov 2019
CLADRIBINE	10MG	tablet · oral	APOTEX	Prescription	24 Nov 2025
CLADRIBINE	10MG	tablet · oral	HOPEWELL PHARMA	Prescription	27 Mar 2026
LEUSTATIN	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	JANSSEN PHARMS	Discontinued	26 Feb 1993
CLADRIBINE	1MG/ML	injectable · injection	PHARMOBEDIENT	Discontinued	6 Oct 2011

EMA European Union — centrally authorised medicines

Litak Lipomed GmbH · Authorised · authorised 14 Apr 2004 · ATC L01BB04

Therapeutic indication (EMA)

Litak is indicated for the treatment of hairy-cell leukaemia.

Mavenclad Merck Europe B.V. · Authorised · authorised 22 Aug 2017 · ATC L04AA40

Therapeutic indication (EMA)

Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.

Movectro Merck Serono Europe Limited · Application withdrawn · ATC L01BB04

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-CLADRIBINE	02553295	10 MG	TABLET · ORAL	APOTEX INC
AURO-CLADRIBINE	02566443	10 MG	TABLET · ORAL	AURO PHARMA INC
CLADRIBINE INJECTION	02319918	1 MG / ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
CLADRIBINE INJECTION	02494574	1 MG / ML	SOLUTION · INTRAVENOUS	GENERIC MEDICAL PARTNERS INC
MAVENCLAD	02470179	10 MG	TABLET · ORAL	EMD SERONO, A DIVISION OF EMD INC., CANADA

WHO WHO Model List of Essential Medicines (2025)

5.1.2. Medicines for multiple sclerosis · complementary
Multiple sclerosis
Oral > Solid > tablet: 10 mg

Safety signals and safety-related labeling changes

US FDA 14 May 2026 MAVENCLAD — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 15 Mar 2022 Cladribine (Mavenclad): new advice to minimise risk of serious liver injury
Liver monitoring requirements for cladribine in the treatment of multiple sclerosis have been introduced following uncommon cases of serious liver injury. Advise patients to seek urgent medical attention if they develop any clinical features of liver dysfunction. Discontinue or interrupt cladribine if significant hepatic injury is confirmed.
EMA PRAC 11 Jun 2020 PRAC signal: Seizure
Action for MAH: update of the product information: No
EMA PRAC 29 Sep 2017 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: Yes
EMA PRAC 5 May 2017 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No

All safety entries for cladribine →

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.