EMA — authorised 24 June 2011
- Application: EMEA/H/C/002069
- Marketing authorisation holder: Lux Biosciences GmbH
- Local brand name: Luveniq
- Indication: treatment of non-infectious uveitis
- Status: withdrawn
🇪🇺 LUPKYNIS in European Union
EMA authorised LUPKYNIS on 24 June 2011
Marketing authorisations
EMA — authorised 15 September 2022
- Application: EMEA/H/C/005256
- Marketing authorisation holder: Otsuka Pharmaceutical Netherlands B.V.
- Local brand name: Lupkynis
- Indication: Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).
- Status: approved
LUPKYNIS 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 LUPKYNIS approved in European Union?
Yes. EMA authorised it on 24 June 2011; EMA authorised it on 15 September 2022.
Who is the marketing authorisation holder for LUPKYNIS in European Union?
Lux Biosciences GmbH holds the EU marketing authorisation.