🇪🇺 Guselkumab (GUS) in European Union

EMA authorised Guselkumab (GUS) on 10 November 2017

Marketing authorisation

EMA — authorised 10 November 2017

  • Application: EMEA/H/C/004271
  • Marketing authorisation holder: Janssen-Cilag International NV
  • Local brand name: Tremfya
  • Indication: Adult plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.  Psoriatic arthritisTremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modi
  • Status: approved

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Guselkumab (GUS) in other countries

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

Other Immunology/Dermatology approved in European Union

Frequently asked questions

Is Guselkumab (GUS) approved in European Union?

Yes. EMA authorised it on 10 November 2017.

Who is the marketing authorisation holder for Guselkumab (GUS) in European Union?

Janssen-Cilag International NV holds the EU marketing authorisation.