🇪🇺 Bedaquiline Oral Tablet in European Union

EMA authorised Bedaquiline Oral Tablet on 5 March 2014

Marketing authorisation

EMA — authorised 5 March 2014

  • Application: EMEA/H/C/002614
  • Marketing authorisation holder: Janssen-Cilag International N.V.
  • Local brand name: Sirturo
  • 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.  
  • Status: approved

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Bedaquiline Oral Tablet in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in European Union

Frequently asked questions

Is Bedaquiline Oral Tablet approved in European Union?

Yes. EMA authorised it on 5 March 2014.

Who is the marketing authorisation holder for Bedaquiline Oral Tablet in European Union?

Janssen-Cilag International N.V. holds the EU marketing authorisation.