🇪🇺 Clarinex in European Union

EMA authorised Clarinex on 15 January 2001

Marketing authorisations

EMA — authorised 15 January 2001

  • Application: EMEA/H/C/000312
  • Marketing authorisation holder: Schering-Plough Europe
  • Local brand name: Allex
  • Indication: Aerius is indicated for the relief of symptoms associated with: allergic rhinitis (see section 5.1) urticaria (see section 5.1)
  • Status: withdrawn

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EMA — authorised 15 January 2001

  • Application: EMEA/H/C/000311
  • Marketing authorisation holder: Schering-Plough Europe
  • Local brand name: Opulis
  • Indication: Opulis is indicated for the relief of symptoms associated with:- allergic rhinitis (see section 5.1)- urticaria (see section 5.1)
  • Status: withdrawn

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EMA — authorised 15 January 2001

  • Application: EMEA/H/C/000314
  • Marketing authorisation holder: Organon N.V.
  • Local brand name: Neoclarityn
  • Indication: Neoclarityn is indicated for the relief of symptoms associated with: allergic rhinitis urticaria
  • Status: approved

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EMA — authorised 15 January 2001

  • Application: EMEA/H/C/000310
  • Marketing authorisation holder: Organon N.V.
  • Local brand name: Azomyr
  • Indication: Azomyr is indicated for the relief of symptoms associated with: allergic rhinitis (see section 5.1) urticaria (see section 5.1)
  • Status: approved

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EMA — authorised 30 July 2007

  • Application: EMEA/H/C/000772
  • Marketing authorisation holder: Organon N.V.
  • Local brand name: Aerinaze
  • Indication: Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
  • Status: approved

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EMA — authorised 23 September 2011

  • Application: EMEA/H/C/002461
  • Marketing authorisation holder: Krka, d.d., Novo mesto
  • Local brand name: Desloratadine Krka
  • Indication: Relief of symptoms of allergic rhinitis and urticaria
  • Status: withdrawn

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EMA — authorised 24 November 2011

  • Application: EMEA/H/C/002419
  • Marketing authorisation holder: Teva B.V
  • Local brand name: Desloratadine Teva
  • Indication: Desloratadine Teva is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.
  • Status: approved

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EMA — authorised 28 November 2011

  • Application: EMEA/H/C/002310
  • Marketing authorisation holder: Krka, d.d., Novo mesto
  • Local brand name: Dasselta
  • Indication: Dasselta is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.
  • Status: approved

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EMA — authorised 13 January 2012

  • Application: EMEA/H/C/002404
  • Marketing authorisation holder: Ratiopharm GmbH
  • Local brand name: Desloratadine ratiopharm
  • Indication: Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with: allergic rhinitis chronic idiopathic urticaria as initially diagnosed by a physician
  • Status: approved

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EMA — authorised 13 January 2012

  • Application: EMEA/H/C/002435
  • Marketing authorisation holder: Actavis Group PTC ehf
  • Local brand name: Desloratadine Actavis
  • Indication: Treatment of allergic rhinitis and urticaria.
  • Status: approved

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EMA

  • Application: EMEA/H/C/000313
  • Local brand name: Aerius
  • Status: approved

Clarinex in other countries

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

Other Metabolic approved in European Union

Frequently asked questions

Is Clarinex approved in European Union?

Yes. EMA authorised it on 15 January 2001; EMA authorised it on 15 January 2001; EMA authorised it on 15 January 2001.

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

Schering-Plough Europe holds the EU marketing authorisation.