Is Natalizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Natalizumab, including TYSABRI 300 MG/15ML (20 mg/ml, Concentrate for solution for infusion, SAR 5558.25); Tyruko (20 mg/ml, Concentrate for solution for infusion, SAR 4004.50); Tysabri (150 mg, Solution for injection in pre-filled syringe, SAR 5558.25).

Is Natalizumab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Natalizumab, including TYSABRI (Prescription); TYRUKO (Prescription).

Is Natalizumab authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Natalizumab: Tysabri, Tyruko.

Are there safety signals or safety updates for Natalizumab?

EMA PRAC: 8 entries; US FDA: 2 entries; MHRA: 3 entries (latest 2025-10-30).

Active substance

Natalizumab

SFDA 3
US FDA 2
EMA 3
Health Canada 1
Safety 13

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TYSABRI 300 MG/15ML	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 5558.25	Biological · Prescription	Biogen Idec B.V-Natherland	Valid
Tyruko	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 4004.50	Biological · Prescription	SANDOZ GMBH	Valid
Tysabri	150 mg	Solution for injection in pre-filled syringe · Subcutaneous use	2 Pre-filled syringe	SAR 5558.25	Biological · Prescription	Biogen Idec B.V-Natherland	Valid

Indications — CHI Daman Drug Formulary

CROHN'S DISEASE; MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
TYSABRI	300MG	vial · single-use	BIOGEN IDEC	Prescription	23 Nov 2004
TYRUKO	300MG/15ML(20MG/ML)	injectable · injection	SANDOZ INC	Prescription	24 Aug 2023

EMA European Union — centrally authorised medicines

Tysabri Biogen Netherlands B.V. · Authorised · authorised 27 Jun 2006 · ATC L04AG03

Therapeutic indication (EMA)

Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Tyruko Sandoz GmbH · Authorised · authorised 22 Sep 2023 · ATC L04AG03

Therapeutic indication (EMA)

Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.

Natalizumab Elan Pharma Elan Pharma International Ltd. · Refused · ATC L03AD

Therapeutic indication (EMA)

Treatment of moderately to severely active Crohn's disease for the reduction of signs and symptoms, and the induction and maintenance of sustained response and remission, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or are intolerant to or have medical contraindications to such therapies.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TYSABRI	02286386	300 MG / 15 ML	SOLUTION · INTRAVENOUS	BIOGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 30 Oct 2025 TYRUKO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Mar 2025 TYSABRI — 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 11 Jul 2019 PRAC signal: Psoriasis
Action for MAH: update of the product information: No
EMA PRAC 15 Mar 2019 PRAC signal: Psoriasis
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Human papillomavirus (HPV) infection and complications
Action for MAH: update of the product information: No
EMA PRAC 13 May 2016 PRAC signal: Necrotising retinitis
Action for MAH: update of the product information: Yes
MHRA 18 Apr 2016 Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy—updated advice to support early detection
Perform a quantitative serum anti-JCV antibody test—including index value—to support risk stratification for progressive multifocal leukoencephalopathy. For high-risk patients, consider more frequent MRI screening.
EMA PRAC 14 Jan 2016 PRAC signal: Necrotising retinitis
Action for MAH: update of the product information: No
EMA PRAC 7 May 2015 PRAC signal: Anaemia
Action for MAH: update of the product information: Yes
MHRA 11 Dec 2014 Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy is increased in patients who have had previous immunosuppressant treatment
Risk of developing progressive multifocal leukoencephalopathy (PML) associated with natalizumab is increased in patients who have had previous immunosuppressant therapy.
MHRA 11 Dec 2014 Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy increases after 2 years of therapy
The risk of developing progressive multifocal leukoencephalopathy (PML) with natalizumab increases after 2 years of therapy. Patients with multiple sclerosis should be informed of the risk before treatment, and again after 2 years. The risk of developing PML beyond 3 years of treatment is currently unknown. Product information for healthcare professionals and patients is being updated with the latest information.
EMA PRAC 4 Dec 2014 PRAC signal: Anaemia
Action for MAH: update of the product information: No
EMA PRAC 11 Sep 2014 PRAC signal: Neonatal haematological abnormalities (thrombocytopenia/anaemia)
Action for MAH: update of the product information: No

All safety entries for natalizumab →

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.