Trogarzo

RSS

ibalizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Trogarzo is a medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Trogarzo is given with other HIV medicines when none of the standard combinations work to control the infection because the virus is resistant to them (multi-drug resistant HIV).

Trogarzo contains the active substance ibalizumab.

This EPAR was last updated on 10/10/2019

Authorisation details

Product details
Name
Trogarzo
Agency product number
EMEA/H/C/004961
Active substance
Ibalizumab
International non-proprietary name (INN) or common name
ibalizumab
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AX
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Theratechnologies International Limited
Date of issue of marketing authorisation valid throughout the European Union
26/09/2019
Contact address

10 Earlsfort Terrace
Dublin 2, D02 T380
Ireland

Product information

26/09/2019 Trogarzo - EMEA/H/C/004961 -

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

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.

Assessment history

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