🇪🇺 Antidepressant Medication in European Union

EMA authorised Antidepressant Medication on 11 August 2004

Marketing authorisations

EMA — authorised 11 August 2004

  • Application: EMEA/H/C/000552
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Ariclaim
  • Indication: Treatment of diabetic peripheral neuropathic pain. Ariclaim is indicated in adults.
  • Status: withdrawn

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EMA — authorised 11 August 2004

  • Application: EMEA/H/C/000545
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Yentreve
  • Indication: Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).
  • Status: approved

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EMA — authorised 17 December 2004

  • Application: EMEA/H/C/000573
  • Marketing authorisation holder: Esteve Pharmaceuticals, S.A.
  • Local brand name: Nodetrip (previously Xeristar)
  • Indication: Treatment of major depressive disorder; Treatment of diabetic peripheral neuropathic pain; Treatment of generalised anxiety disorder; Xeristar is indicated in adults.
  • Status: withdrawn

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EMA — authorised 8 October 2008

  • Application: EMEA/H/C/001007
  • Marketing authorisation holder: Boehringer Ingelheim International GmbH
  • Local brand name: Duloxetine Boehringer Ingelheim
  • Indication: Treatment of diabetic peripheral neuropathic pain in adults.
  • Status: withdrawn

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EMA — authorised 8 December 2014

  • Application: EMEA/H/C/004000
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Duloxetine Lilly
  • Indication: Duloxetine Lilly is indicated in adults for: Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Lilly is indicated in adults.
  • Status: approved

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EMA — authorised 24 April 2015

  • Application: EMEA/H/C/004009
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Duloxetine Sandoz
  • Indication: Treatment in adults of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder.
  • Status: withdrawn

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EMA — authorised 19 June 2015

  • Application: EMEA/H/C/003981
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Duloxetine Viatris (previously Duloxetine Mylan)
  • Indication: Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Viatris is indicated in adults
  • Status: approved

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EMA — authorised 20 August 2015

  • Application: EMEA/H/C/003935
  • Marketing authorisation holder: Zentiva, k.s.
  • Local brand name: Duloxetine Zentiva
  • Indication: Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder. Duloxetine Zentiva is indicated in adults.
  • Status: approved

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Antidepressant Medication 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 Antidepressant Medication approved in European Union?

Yes. EMA authorised it on 11 August 2004; EMA authorised it on 11 August 2004; EMA authorised it on 17 December 2004.

Who is the marketing authorisation holder for Antidepressant Medication in European Union?

Eli Lilly Nederland B.V. holds the EU marketing authorisation.