🇪🇺 paracetamol + pregabalin + dexamethasone in European Union

EMA authorised paracetamol + pregabalin + dexamethasone on 10 April 2014

Marketing authorisations

EMA — authorised 10 April 2014

  • Application: EMEA/H/C/003880
  • Marketing authorisation holder: Viatris Healthcare Limited
  • Local brand name: Pregabalin Viatris Pharma (previously Pregabalin Pfizer)
  • Indication: Neuropathic painPregabalin Viatris Pharma is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Viatris Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Viatris Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
  • Status: approved

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EMA — authorised 19 June 2015

  • Application: EMEA/H/C/004010
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Pregabalin Sandoz
  • Indication: Neuropathic pain Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
  • Status: approved

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EMA — authorised 19 June 2015

  • Application: EMEA/H/C/004070
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Pregabalin Sandoz GmbH
  • Indication: Epilepsy Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
  • Status: withdrawn

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EMA — authorised 24 June 2015

  • Application: EMEA/H/C/004078
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Pregabalin Viatris (previously Pregabalin Mylan)
  • Indication: Neuropathic pain Pregabalin Viatris is indicated for the treatment of peripheral and central neuropathic pain in adults. EpilepsyPregabalin Viatris is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety DisorderPregabalin Viatris is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
  • Status: approved

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EMA — authorised 25 June 2015

  • Application: EMEA/H/C/003962
  • Marketing authorisation holder: Mylan S.A.S.
  • Local brand name: Pregabalin Mylan Pharma
  • Indication: Epilepsy Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
  • Status: withdrawn

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EMA — authorised 17 July 2015

  • Application: EMEA/H/C/003900
  • Marketing authorisation holder: Zentiva, k.s.
  • Local brand name: Pregabalin Zentiva
  • Indication: Neuropathic pain Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
  • Status: approved

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EMA — authorised 28 August 2015

  • Application: EMEA/H/C/004024
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Pregabalin Accord
  • Indication: Epilepsy Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
  • Status: approved

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EMA — authorised 27 February 2017

  • Application: EMEA/H/C/004277
  • Marketing authorisation holder: Zentiva k.s.
  • Local brand name: Pregabalin Zentiva k.s.
  • Indication: Neuropathic pain Pregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Pregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
  • Status: withdrawn

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paracetamol + pregabalin + dexamethasone 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 paracetamol + pregabalin + dexamethasone approved in European Union?

Yes. EMA authorised it on 10 April 2014; EMA authorised it on 19 June 2015; EMA authorised it on 19 June 2015.

Who is the marketing authorisation holder for paracetamol + pregabalin + dexamethasone in European Union?

Viatris Healthcare Limited holds the EU marketing authorisation.