🇪🇺 risankizumab SC in European Union

EMA authorised risankizumab SC on 26 April 2019

Marketing authorisation

Application: EMEA/H/C/004759
Marketing authorisation holder: AbbVie Deutschland GmbH & Co. KG
Local brand name: Skyrizi
Indication: Plaque PsoriasisSkyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Psoriatic ArthritisSkyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Crohn’s diseaseSkyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to,
Status: approved

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

Is risankizumab SC approved in European Union?

Yes. EMA authorised it on 26 April 2019.

Who is the marketing authorisation holder for risankizumab SC in European Union?

AbbVie Deutschland GmbH & Co. KG holds the EU marketing authorisation.