Is Alemtuzumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Alemtuzumab, including LEMTRADA 12 MG CONCENTRATE FOR SOLUTION FOR INFUSION (12 mg, Concentrate for solution for infusion, SAR 32921.25).

Is Alemtuzumab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Alemtuzumab, including CAMPATH (Prescription); LEMTRADA (Prescription).

Is Alemtuzumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Alemtuzumab: Lemtrada.

Are there safety signals or safety updates for Alemtuzumab?

EMA PRAC: 7 entries; US FDA: 2 entries (latest 2024-02-08).

Active substance

Alemtuzumab

SFDA 1
US FDA 2
EMA 2
Health Canada 2
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LEMTRADA 12 MG CONCENTRATE FOR SOLUTION FOR INFUSION	12 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 32921.25	Biological · Prescription	Sanofi Belgium	Valid

Indications — CHI Daman Drug Formulary

APLASTIC ANEMIA; MULTIPLE SCLEROSIS; RENAL TRANSPLANT; T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
CAMPATH	10MG/ML; 30MG/ML	vial · intravenous	GENZYME	Prescription	7 May 2001
LEMTRADA	12MG/1.2ML (10MG/ML)	injectable · injection	GENZYME	Prescription	7 May 2001

EMA European Union — centrally authorised medicines

Lemtrada Sanofi Belgium · Authorised · authorised 12 Sep 2013 · ATC L04AA34

Therapeutic indication (EMA)

Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

MabCampath Genzyme Europe B.V. · Withdrawn · authorised 6 Jul 2001 · ATC L01XC04

Therapeutic indication (EMA)

MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LEMTRADA	02418320	12 MG / 1.2 ML	SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC
MABCAMPATH	02290960	30 MG / ML	SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 8 Feb 2024 LEMTRADA — 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
US FDA 26 Apr 2023 CAMPATH — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Mar 2022 PRAC signal: Vitiligo
Action for MAH: update of the product information: Yes
EMA PRAC 28 Oct 2021 PRAC signal: Vitiligo
Action for MAH: update of the product information: No
EMA PRAC 2 Sep 2021 PRAC signal: Autoimmune encephalitis
Action for MAH: update of the product information: No
EMA PRAC 6 May 2021 PRAC signal: Sarcoidosis
Action for MAH: update of the product information: Yes
EMA PRAC 14 Jan 2021 PRAC signal: Sarcoidosis
Action for MAH: update of the product information: No
EMA PRAC 6 Sep 2018 PRAC signal: Cytomegalovirus (CMV) infection
Action for MAH: update of the product information: Yes
EMA PRAC 12 Apr 2018 PRAC signal: Cytomegalovirus (CMV) infection
Action for MAH: update of the product information: No

All safety entries for alemtuzumab →

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.