This is the pharmaceutical Joint Assessment PTJA14 – Pretomanid 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).
In August, 2020, the European Commission granted marketing authorisation for pretomanide (pretomanid FGK) in combination with bedaquiline and linezolid for the treatment of pulmonary extensively drug-resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Publication of this PTJA14 was postponed by 5 weeks due to the unavailability of the EPAR. This Joint Assessment aims to compare the clinical effectiveness and safety of pretomanid in the target patient populations with relevant comparators, according to the national requirements of EUnetHTA partners.
Below is the documentation provided by the Joint Assessment authoring team (project plan, assessment report and responses to the factual accuracy check performed by Mylan; and the Core Submission Dossier prepared by Mylan, the Marketing Authorisation Holder of pretomanid).
For any questions regarding the assessment, please contact WP4_Pharmaceuticals@zinl.nl
PTJA14 – Final Project Plan
PTJA14 – Final Assessment Report
PTJA14 – Plain Language Summary
PTJA14 – MAH Core Submission Dossier
PTJA14 – External Comments – Factual Accuracy Check MAH
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