🇪🇺 Higher bioavailability BNX sublingual tablets in European Union

EMA authorised Higher bioavailability BNX sublingual tablets on 10 November 2017

Marketing authorisation

EMA — authorised 10 November 2017

  • Application: EMEA/H/C/004407
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Zubsolv
  • Indication: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
  • Status: approved

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Higher bioavailability BNX sublingual tablets in other countries

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

Frequently asked questions

Is Higher bioavailability BNX sublingual tablets approved in European Union?

Yes. EMA authorised it on 10 November 2017.

Who is the marketing authorisation holder for Higher bioavailability BNX sublingual tablets in European Union?

Accord Healthcare S.L.U. holds the EU marketing authorisation.