Is Ocrelizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Ocrelizumab, including OCREVUS 30 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION (300 mg, Concentrate for solution for infusion, SAR 20981.40); Ocrevus (40 mg/ml, Solution for injection, SAR 41962.80).

Is Ocrelizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Ocrelizumab, including OCREVUS (Prescription).

Is Ocrelizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ocrelizumab: Ocrevus.

Are there safety signals or safety updates for Ocrelizumab?

US FDA: 1 entry (latest 2026-05-08).

Active substance

Ocrelizumab

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OCREVUS 30 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION	300 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 20981.40	Biological · Prescription	F.Hoffmann-La Roche Ltd.	Valid
Ocrevus	40 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 41962.80	Biological · Prescription	F.Hoffmann-La Roche Ltd.	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
OCREVUS	30MG/1ML	injectable · injection	GENENTECH INC	Prescription	28 Mar 2017

EMA European Union — centrally authorised medicines

Ocrevus Roche Registration GmbH · Authorised · authorised 8 Jan 2018 · ATC L04AG08

Therapeutic indication (EMA)

Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OCREVUS	02467224	30 MG / ML	SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 8 May 2026 OCREVUS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ocrelizumab →

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.