🇪🇺 Sirturo in European Union

Sirturo (bedaquiline) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/002614
  • Local brand name: Sirturo
  • Status: approved

Sirturo 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 Sirturo approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for Sirturo in European Union?

Janssen Therap is the originator. The local marketing authorisation holder may differ — check the official source linked above.