🇪🇺 Pharmacologic Pain Management in European Union

EMA authorised Pharmacologic Pain Management on 19 June 2019

Marketing authorisations

EMA — authorised 19 June 2019

  • Application: EMEA/H/C/004743
  • Marketing authorisation holder: L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
  • Local brand name: Sixmo
  • Indication: Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
  • Status: withdrawn

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EMA — authorised 19 December 2024

  • Application: EMEA/H/C/006188
  • Marketing authorisation holder: Neuraxpharm Pharmaceuticals S.L.
  • Local brand name: Buprenorphine Neuraxpharm
  • Indication: Substitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents 15 years of age and older, who have agreed to be treated for addiction.
  • Status: approved

The European Medicines Agency (EMA) granted marketing authorisation for Buprenorphine Neuraxpharm, a pharmacologic pain management product, on 19 December 2024. This authorisation is for the substitution treatment of opioid drug dependence in adults and adolescents 15 years and older, within a comprehensive therapeutic monitoring framework. The treatment is intended for use in patients who have agreed to be treated for addiction.

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Pharmacologic Pain Management in other countries

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

Other Pain Management approved in European Union

Frequently asked questions

Is Pharmacologic Pain Management approved in European Union?

Yes. EMA authorised it on 19 June 2019; EMA authorised it on 19 December 2024.

Who is the marketing authorisation holder for Pharmacologic Pain Management in European Union?

L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. holds the EU marketing authorisation.