Overview
The marketing authorisation for Trogarzo has been withdrawn at the request of the marketing-authorisation holder.
Trogarzo : EPAR - Medicine overview
Trogarzo : EPAR - Risk-management-plan summary
Product information
Trogarzo : EPAR - Product Information
Latest procedure affecting product information: IAIN/0020
12/10/2022
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
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 useTherapeutic 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
Trogarzo : EPAR - Procedural steps taken and scientific information after authorisation