Sirturo is a tuberculosis medicine that contains the active substance bedaquiline. Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis.
Sirturo is used in combination with other tuberculosis medicines in adults and adolescents (aged 12 years and older and weighing at least 30 kg) with tuberculosis in the lung that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines). It is given when other combinations cannot be used, either because the disease is resistant to them or because of their side effects.
Sirturo : EPAR - Medicine overview (PDF/130.68 KB)
First published: 14/03/2014
Last updated: 19/02/2020
Sirturo : EPAR - Risk-management-plan summary (PDF/133.92 KB)
First published: 14/03/2014
Last updated: 06/03/2020
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
Janssen-Cilag International N.V.
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13/02/2020 Sirturo - EMEA/H/C/002614 - II/0038
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (MDR TB) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 201913/12/2019
World TB Day – three new medicines recommended in last six months for patients with multidrug-resistant tuberculosis21/03/2014
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 December 201320/12/2013
European Medicines Agency recommends approval of a new medicine for multidrug-resistant tuberculosis20/12/2013