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Pretomanid

Subject:

  • Active Substance: Pretomanid in combination with bedaquiline and linezolid
  • Name: Pretomanid FGK
  • Therapeutic area: Pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB)
  • Pharmaceutical company: FGK Representative Service GmbH

 

Time table:

  • Publication of project plan: 02.04.2020
  • Publication of final assessment: 19.08.2020

 

Assessment information:

  • Title: Pretomanid FGK is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB)
  • Author/Co-Author: HAS (France), MIZ (Croatia)
  • Dedicated Reviewers: MoH (Ukraine), SNHTA (Switzerland), AEMPS (Spain), UU (Netherlands)