EMA — authorised 24 March 2023
- Marketing authorisation holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
- Status: approved
🇪🇺 Sotyktu in European Union
EMA authorised Sotyktu on 24 March 2023
Marketing authorisations
EMA — authorised 24 March 2023
- Application: EMEA/H/C/005755
- Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
- Local brand name: Sotyktu
- Indication: Plaque psoriasis Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Sotyktu, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy.
- Status: approved
Sotyktu in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in European Union
Frequently asked questions
Is Sotyktu approved in European Union?
Yes. EMA authorised it on 24 March 2023; EMA authorised it on 24 March 2023.
Who is the marketing authorisation holder for Sotyktu in European Union?
BRISTOL-MYERS SQUIBB PHARMA EEIG holds the EU marketing authorisation.