Is Faricimab 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 Faricimab, including Vabysmo (120 mg/ml, Solution for injection in pre-filled syringe, SAR 3720.75); Vabysmo 6 mg per 0.05 ml (120 mg/ml, Solution for injection, SAR 3720.75).

Is Faricimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Faricimab, including VABYSMO (Prescription).

Is Faricimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Faricimab: Vabysmo.

Are there safety signals or safety updates for Faricimab?

US FDA: 1 entry (latest 2023-10-26).

Active substance

Faricimab

SFDA 2
US FDA 1
EMA 1
Health Canada 2
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
Vabysmo	120 mg/ml	Solution for injection in pre-filled syringe · Intravitreal use	1 Pre-filled syringe	SAR 3720.75	Biological · Prescription	F.Hoffmann-La Roche Ltd.	Valid
Vabysmo 6 mg per 0.05 ml	120 mg/ml	Solution for injection · Intravitreal use	1 Vial	SAR 3720.75	Biological · Prescription	F.Hoffmann-La Roche Ltd.	Valid

Indications — CHI Daman Drug Formulary

AGE RELATED MACULAR DEGENERATION; DIABETIC MACULAR EDEMA (DME)

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

Product	Strength	Form · route	Applicant	Status	First approved
VABYSMO	120MG/ML	injectable · intravitreal	GENENTECH INC	Prescription	28 Jan 2022

EMA European Union — centrally authorised medicines

Vabysmo Roche Registration GmbH · Authorised · authorised 15 Sep 2022 · ATC S01L

Therapeutic indication (EMA)

Vabysmo is indicated for the treatment of adult patients with: neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular oedema (DME), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VABYSMO	02527618	6 MG / 0.05 ML	SOLUTION · INTRAVITREAL	HOFFMANN-LA ROCHE LIMITED
VABYSMO	02554003	6 MG / 0.05 ML	SOLUTION · INTRAVITREAL	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 26 Oct 2023 VABYSMO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for faricimab →

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.