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)