Is Obinutuzumab 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 Obinutuzumab, including GAZYVA 25 mg/ml concentrate for solution for infusion (25 mg/ml, Concentrate for solution for infusion, SAR 14662.70).

Is Obinutuzumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Obinutuzumab, including GAZYVA (Prescription).

Is Obinutuzumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Obinutuzumab: Gazyvaro.

Are there safety signals or safety updates for Obinutuzumab?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-09-25).

Active substance

Obinutuzumab

SFDA 1
US FDA 1
EMA 1
Health Canada 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
GAZYVA 25 mg/ml concentrate for solution for infusion	25 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 14662.70	NCE · Prescription	ROCHE	Valid

Indications — CHI Daman Drug Formulary

CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B CELL LYMPHOMA; FOLLICULAR LYMPHOMA; MARGINAL ZONE LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
GAZYVA	1000MG/40ML	injectable · injection	GENENTECH	Prescription	1 Nov 2013

EMA European Union — centrally authorised medicines

Gazyvaro Roche Registration GmbH · Authorised · authorised 22 Jul 2014 · ATC L01FA03

Therapeutic indication (EMA)

Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy. Follicular Lymphoma (FL) Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma. Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. Lupus nephritis (LN) Gazyvaro in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
GAZYVA	02434806	25 MG / ML	SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 25 Sep 2026 GAZYVA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Feb 2022 PRAC signal: Non-overt disseminated intravascular coagulation (DIC)
Action for MAH: update of the product information: Yes
EMA PRAC 2 Sep 2021 PRAC signal: Non-overt disseminated intravascular coagulation (DIC)
Action for MAH: update of the product information: No

All safety entries for obinutuzumab →

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.