Trogarzo

RSS
Withdrawn

This medicine's authorisation has been withdrawn

ibalizumab
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 1 January 2023, the European Commission withdrew the marketing authorisation for Trogarzo (ibalizumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Theratechnologies Europe Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Trogarzo was granted marketing authorisation in the EU on 26 September 2019 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. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Trogarzo is updated to indicate that the marketing authorisation is no longer valid.

Trogarzo : EPAR - Medicine overview

Reference Number: EMA/502446/2019

English (EN) (665.94 KB - PDF)

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български (BG) (729.99 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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español (ES) (657.7 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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čeština (CS) (716.14 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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dansk (DA) (656.3 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Deutsch (DE) (663.12 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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eesti keel (ET) (73.34 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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ελληνικά (EL) (763.57 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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français (FR) (662.39 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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hrvatski (HR) (679.34 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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italiano (IT) (656.3 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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latviešu valoda (LV) (716.2 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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lietuvių kalba (LT) (680.41 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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magyar (HU) (728.36 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Malti (MT) (724.22 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Nederlands (NL) (657.17 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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polski (PL) (714.21 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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português (PT) (660.99 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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română (RO) (681.06 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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slovenčina (SK) (715.17 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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slovenščina (SL) (708.72 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Suomi (FI) (656.28 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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svenska (SV) (656.95 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Trogarzo : EPAR - Risk-management-plan summary

English (EN) (667.56 KB - PDF)

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Product information

Trogarzo : EPAR - Product Information

English (EN) (1.15 MB - PDF)

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български (BG) (1.74 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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español (ES) (1.16 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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čeština (CS) (1.6 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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dansk (DA) (997.86 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Deutsch (DE) (1.02 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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eesti keel (ET) (301.99 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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ελληνικά (EL) (1.68 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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français (FR) (1014.56 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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hrvatski (HR) (1.05 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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íslenska (IS) (922.11 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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italiano (IT) (1.01 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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latviešu valoda (LV) (1.54 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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lietuvių kalba (LT) (1.1 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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magyar (HU) (1.49 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Malti (MT) (1.52 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Nederlands (NL) (1.01 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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norsk (NO) (1.03 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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polski (PL) (1.42 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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português (PT) (1 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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română (RO) (1.1 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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slovenčina (SK) (1.43 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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slovenščina (SL) (1.37 MB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Suomi (FI) (1017 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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svenska (SV) (960.21 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Latest procedure affecting product information:IAIN/0020
12/10/2022
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Trogarzo : EPAR - All authorised presentations

English (EN) (598.16 KB - PDF)

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български (BG) (624.09 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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español (ES) (580.88 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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čeština (CS) (612.33 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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dansk (DA) (580.45 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Deutsch (DE) (580.84 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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eesti keel (ET) (9.68 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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ελληνικά (EL) (623.37 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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français (FR) (580.53 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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hrvatski (HR) (595.43 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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íslenska (IS) (599.47 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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italiano (IT) (580.88 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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latviešu valoda (LV) (616.44 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
View

lietuvių kalba (LT) (595.46 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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magyar (HU) (602.71 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Malti (MT) (614.78 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Nederlands (NL) (580.63 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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norsk (NO) (600.04 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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polski (PL) (613.79 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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português (PT) (580.71 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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română (RO) (597.59 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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slovenčina (SK) (611.37 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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slovenščina (SL) (602.75 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Suomi (FI) (580.44 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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svenska (SV) (580.68 KB - PDF)

First published: 10/10/2019 Last updated: 16/01/2023
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Product details

Name of medicine
Trogarzo
Active substance
Ibalizumab
International non-proprietary name (INN) or common name
ibalizumab
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AX

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.

Authorisation details

EMA product number
EMEA/H/C/004961
Marketing authorisation holder
Theratechnologies Europe Limited

4th Floor
2 Hume Street
Dublin 2
D02 DV24
Ireland

Opinion adopted
25/07/2019
Marketing authorisation issued
26/09/2019
Withdrawal of marketing authorisation
01/01/2023
Revision
7

Assessment history

Trogarzo : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (997.53 KB - PDF)

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Trogarzo : EPAR - Public assessment report

Adopted Reference Number: EMA/469134/2019

English (EN) (4.2 MB - PDF)

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CHMP summary of positive opinion for Trogarzo

Adopted Reference Number: EMA/CHMP/85932/2019

English (EN) (705.5 KB - PDF)

First published: Last updated:
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