🇪🇺 Apremilast IR in European Union

EMA authorised Apremilast IR on 15 January 2015

Marketing authorisation

EMA — authorised 15 January 2015

  • Application: EMEA/H/C/003746
  • Marketing authorisation holder: Amgen Europe B.V.
  • Local brand name: Otezla
  • Indication: Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis (PSOR) in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediat
  • Status: approved

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Apremilast IR 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 Apremilast IR approved in European Union?

Yes. EMA authorised it on 15 January 2015.

Who is the marketing authorisation holder for Apremilast IR in European Union?

Amgen Europe B.V. holds the EU marketing authorisation.