Trogarzo
Withdrawn
This medicine's authorisation has been withdrawn
ibalizumab
MedicineHumanWithdrawn
- 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The European Public Assessment Report (EPAR) for Trogarzo is updated to indicate that the marketing authorisation is no longer valid.
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).
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.
News on Trogarzo
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