🇪🇺 ibalizumab-uiyk in European Union

EMA authorised ibalizumab-uiyk on 26 September 2019

Marketing authorisation

EMA — authorised 26 September 2019

  • Application: EMEA/H/C/004961
  • Marketing authorisation holder: Theratechnologies Europe Limited
  • Local brand name: Trogarzo
  • 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.
  • Status: withdrawn

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ibalizumab-uiyk in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in European Union

Frequently asked questions

Is ibalizumab-uiyk approved in European Union?

Yes. EMA authorised it on 26 September 2019.

Who is the marketing authorisation holder for ibalizumab-uiyk in European Union?

Theratechnologies Europe Limited holds the EU marketing authorisation.