EMA — authorised 14 February 2022
- Marketing authorisation holder: ASTRA ZENECA AB
- Status: approved
🇪🇺 Saphnelo in European Union
EMA authorised Saphnelo on 14 February 2022
Marketing authorisations
EMA — authorised 14 February 2022
- Application: EMEA/H/C/004975
- Marketing authorisation holder: AstraZeneca AB
- Local brand name: Saphnelo
- Indication: Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.
- Status: approved
Saphnelo 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 Saphnelo approved in European Union?
Yes. EMA authorised it on 14 February 2022; EMA authorised it on 14 February 2022.
Who is the marketing authorisation holder for Saphnelo in European Union?
ASTRA ZENECA AB holds the EU marketing authorisation.