Bedaquiline fumarate
Approved · EMAAlso known as Sirturo, bedaquiline (as fumarate).
Recent clinical, regulatory, research and industry developments relating to this drug.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Sirturo is indicated for use as part of an appropriate combination regimen in adult and paediatric patients (2 years to less than 18 years of age and weighing at least 7 kg)… Show full indicationShow less
Sirturo is indicated for use as part of an appropriate combination regimen in adult and paediatric patients (2 years to less than 18 years of age and weighing at least 7 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
- RxNorm (U.S. National Library of Medicine) — drug identity
- Regulatory event sources are credited in the Regulatory Timeline above.