Lupkynis (voclosporin)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- voclosporin
- Company
- Otsuka Pharmaceutical Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Lupus Nephritis
- CHMP opinion
- Thu 21 Jul 2022
- EU approval
- Thu 15 Sep 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005256
- ATC
- L04AD03
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Luveniq Application withdrawn · Lux Biosciences GmbH
Follow Lupkynis
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.