Sirturo

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bedaquiline

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

Tuberculosis is rare in the EU, and Sirturo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 26 August 2005. Further information on the orphan designationEU/3/05/314.

This EPAR was last updated on 06/03/2020

Authorisation details

Product details
Name
Sirturo
Agency product number
EMEA/H/C/002614
Active substance
bedaquiline fumarate
International non-proprietary name (INN) or common name
bedaquiline
Therapeutic area (MeSH)
Tuberculosis, Multidrug-Resistant
Anatomical therapeutic chemical (ATC) code
J04AK05
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

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.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
05/03/2014
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

13/02/2020 Sirturo - EMEA/H/C/002614 - II/0038

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Pharmacotherapeutic group

Antimycobacterials

Therapeutic indication

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.

Assessment history

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