Sirturo (bedaquiline)
- Region
- 🇪🇺 EU
- Active substance
- bedaquiline
- Status
- Authorised
- Therapeutic area
- Tuberculosis, Multidrug-Resistant
- EU approval
- Wed 05 Mar 2014
- Application
- EMEA/H/C/002614
- ATC
- J04AK05
- Official record
- www.ema.europa.eu
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) 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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.