Is Ibalizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Ibalizumab, including TROGARZO (Prescription).

Is Ibalizumab authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Ibalizumab.

Are there safety signals or safety updates for Ibalizumab?

US FDA: 1 entry (latest 2023-12-12).

Active substance

Ibalizumab

US FDA 1
EMA 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
TROGARZO	150MG/ML	injectable · injection	THERATECHNOLOGIES	Prescription	6 Mar 2018

EMA European Union — centrally authorised medicines

Trogarzo Theratechnologies Europe Limited · Withdrawn · authorised 26 Sep 2019 · ATC J05AX

Therapeutic indication (EMA)

Trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.

Safety signals and safety-related labeling changes

US FDA 12 Dec 2023 TROGARZO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ibalizumab →

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.