Is Glofitamab 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 Glofitamab, including Columvi (1 mg/ml, Concentrate for solution for infusion, SAR 3630.00).

Is Glofitamab approved by the US FDA?

Drugs@FDA lists 1 application product line for Glofitamab, including COLUMVI (Prescription).

Is Glofitamab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Glofitamab: Columvi.

Are there safety signals or safety updates for Glofitamab?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-06-22).

Active substance

Glofitamab

SFDA 2
US FDA 1
EMA 1
Health Canada 2
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
Columvi	1 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 3630.00	Biological · Prescription	F.Hoffmann-La Roche Ltd.	Valid
Columvi	1 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 14520.00	Biological · Prescription	F.Hoffmann-La Roche Ltd.	Valid

Indications — CHI Daman Drug Formulary

DIFFUSE LARGE B CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
COLUMVI	2.5MG/2.5ML(1MG/ML); 10MG/10ML(1MG/ML)	injectable · injection	GENENTECH INC	Prescription	15 Jun 2023

EMA European Union — centrally authorised medicines

Columvi Roche Registration GmbH · Authorised · authorised 7 Jul 2023 · ATC L01FX28

Therapeutic indication (EMA)

Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
COLUMVI	02536552	2.5 MG / 2.5 ML	SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED
COLUMVI	02536560	10 MG / 10 ML	SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 22 Jun 2026 COLUMVI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jul 2024 PRAC signal: Immune effector cell-associated neurotoxicity syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 7 Mar 2024 PRAC signal: Immune effector cell-associated neurotoxicity syndrome
Action for MAH: update of the product information: No

All safety entries for glofitamab →

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.