Trogarzo (ibalizumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- ibalizumab
- Company
- Theratechnologies Europe Limited
- Status
- Withdrawn
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 25 Jul 2019
- EU approval
- Thu 26 Sep 2019
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004961
- ATC
- J05AX
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.