Is Ofatumumab 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 Ofatumumab, including Kesimpta (20 mg/ml, Solution for injection in pre-filled pen, SAR 4344.95).

Is Ofatumumab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Ofatumumab, including ARZERRA (Prescription); KESIMPTA (Prescription).

Is Ofatumumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ofatumumab: Kesimpta.

Are there safety signals or safety updates for Ofatumumab?

US FDA: 1 entry; MHRA: 2 entries (latest 2026-04-01).

Active substance

Ofatumumab

SFDA 5
US FDA 2
EMA 2
Health Canada 1
US price lines 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Kesimpta	20 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 4344.95	Biological · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
ARZERRA	20 mg/ml	Concentrate for solution for infusion · Intravenous use	3 Vial	SAR 3210.80	NCE · Prescription	NOVARTIS PHARMA AG	Withdrawn by MAH · Not Marketed
ARZERRA	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 10702.70	NCE · Prescription	NOVARTIS PHARMA AG	Withdrawn by MAH · Not Marketed
ARZERRA	20 mg/ml	Concentrate for solution for infusion · Intravenous use	3 Vial	SAR 3571.90	NCE · Prescription	GLAXO OPERATION	Withdrawn by MAH · Not Marketed
ARZERRA	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 11906.35	NCE · Prescription	GLAXO OPERATION	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
ARZERRA	100MG/5ML	injectable · injection	NOVARTIS	Prescription	26 Oct 2009
KESIMPTA	20MG/0.4ML	solution · subcutaneous	NOVARTIS	Prescription	26 Oct 2009

EMA European Union — centrally authorised medicines

Kesimpta Novartis Europharm Limited · Authorised · authorised 26 Mar 2021 · ATC L04AA52

Therapeutic indication (EMA)

Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).

Arzerra Novartis Europharm Ltd · Withdrawn · authorised 19 Apr 2010 · ATC L01XC10

Therapeutic indication (EMA)

Previously untreated chronic lymphocytic leukaemia (CLL): Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Relapsed CLL: Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL. Refractory CLL: Arzerra is indicated for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KESIMPTA	02511355	20 MG / 0.4 ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	KESIMPTA 20 MG/0.4 ML PEN	$24369.36944	per ML	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 1 Apr 2026 KESIMPTA — 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
MHRA 11 Dec 2014 Ofatumumab▼: reminder of risk of serious and fatal infusion reactions
Serious and fatal infusion reactions have occurred with ofatumumab and other anti-CD20 monoclonal antibodies. We remind you to always give premedication before each ofatumumab infusion. If a severe reaction occurs, interrupt ofatumumab infusion and treat the reaction.
MHRA 11 Dec 2014 Ofatumumab: screen for hepatitis B virus before treatment
Patients with active infection with this virus should not be treated with ofatumumab.

All safety entries for ofatumumab →

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.