Overview

The marketing authorisation for Trogarzo has been withdrawn at the request of the marketing-authorisation holder.

Trogarzo : EPAR - Medicine overview

Reference Number: EMA/502446/2019

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dansk (DA) (656.3 KB - PDF)

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Deutsch (DE) (663.12 KB - PDF)

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eesti keel (ET) (73.34 KB - PDF)

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ελληνικά (EL) (763.57 KB - PDF)

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français (FR) (662.39 KB - PDF)

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hrvatski (HR) (679.34 KB - PDF)

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italiano (IT) (656.3 KB - PDF)

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latviešu valoda (LV) (716.2 KB - PDF)

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lietuvių kalba (LT) (680.41 KB - PDF)

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magyar (HU) (728.36 KB - PDF)

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Malti (MT) (724.22 KB - PDF)

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Nederlands (NL) (657.17 KB - PDF)

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polski (PL) (714.21 KB - PDF)

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português (PT) (660.99 KB - PDF)

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română (RO) (681.06 KB - PDF)

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slovenčina (SK) (715.17 KB - PDF)

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slovenščina (SL) (708.72 KB - PDF)

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Suomi (FI) (656.28 KB - PDF)

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svenska (SV) (656.95 KB - PDF)

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Trogarzo : EPAR - Risk-management-plan summary

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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)

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español (ES) (1.16 MB - PDF)

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čeština (CS) (1.6 MB - PDF)

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dansk (DA) (997.86 KB - PDF)

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Deutsch (DE) (1.02 MB - PDF)

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eesti keel (ET) (301.99 KB - PDF)

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ελληνικά (EL) (1.68 MB - PDF)

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français (FR) (1014.56 KB - PDF)

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hrvatski (HR) (1.05 MB - PDF)

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íslenska (IS) (922.11 KB - PDF)

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italiano (IT) (1.01 MB - PDF)

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latviešu valoda (LV) (1.54 MB - PDF)

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lietuvių kalba (LT) (1.1 MB - PDF)

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magyar (HU) (1.49 MB - PDF)

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Malti (MT) (1.52 MB - PDF)

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Nederlands (NL) (1.01 MB - PDF)

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norsk (NO) (1.03 MB - PDF)

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polski (PL) (1.42 MB - PDF)

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português (PT) (1 MB - PDF)

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română (RO) (1.1 MB - PDF)

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slovenčina (SK) (1.43 MB - PDF)

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slovenščina (SL) (1.37 MB - PDF)

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Suomi (FI) (1017 KB - PDF)

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svenska (SV) (960.21 KB - PDF)

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

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čeština (CS) (612.33 KB - PDF)

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

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Deutsch (DE) (580.84 KB - PDF)

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eesti keel (ET) (9.68 KB - PDF)

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ελληνικά (EL) (623.37 KB - PDF)

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français (FR) (580.53 KB - PDF)

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hrvatski (HR) (595.43 KB - PDF)

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íslenska (IS) (599.47 KB - PDF)

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

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

First published: 10/10/2019Last updated: 16/01/2023
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lietuvių kalba (LT) (595.46 KB - PDF)

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magyar (HU) (602.71 KB - PDF)

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Malti (MT) (614.78 KB - PDF)

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Nederlands (NL) (580.63 KB - PDF)

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norsk (NO) (600.04 KB - PDF)

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polski (PL) (613.79 KB - PDF)

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português (PT) (580.71 KB - PDF)

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

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

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

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

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

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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
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

AdoptedReference Number: EMA/469134/2019

English (EN) (4.2 MB - PDF)

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CHMP summary of positive opinion for Trogarzo

AdoptedReference Number: EMA/CHMP/85932/2019

English (EN) (705.5 KB - PDF)

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More information on Trogarzo

Public statement on Trogarzo : Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/866352/2022

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