Trogarzo
ibalizumab
Table of contents
Overview
The marketing authorisation for Trogarzo has been withdrawn at the request of the marketing-authorisation holder.
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List item
Trogarzo : EPAR - Medicine overview (PDF/665.94 KB)
First published: 10/10/2019
Last updated: 16/01/2023
EMA/502446/2019 -
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Trogarzo : EPAR - Risk-management-plan summary (PDF/667.56 KB)
First published: 10/10/2019
Last updated: 16/01/2023
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 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 Europe Limited
|
| Revision |
7
|
| Date of issue of marketing authorisation valid throughout the European Union |
26/09/2019
|
| Contact address |
4th Floor |
Product information
12/10/2022 Trogarzo - EMEA/H/C/004961 - IAIN/0020
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.