Opzelura (ruxolitinib)
- Region
- 🇪🇺 EU
- Active substance
- ruxolitinib
- Company
- Incyte Biosciences Distribution B.V.
- Status
- Authorised
- Therapeutic area
- Vitiligo; Dermatitis, Atopic
- CHMP opinion
- Thu 23 Feb 2023
- EU approval
- Wed 19 Apr 2023
- Application
- EMEA/H/C/005843
- ATC
- D11AH09
- Official record
- www.ema.europa.eu
Indication
Vitiligo Opzelura is indicated for the treatment of non segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Atopic dermatitis Opzelura is indicated for the treatment of moderate atopic dermatitis in adult patients for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ruxolitinib Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Ruxolitinib Krka Opinion · KRKA tovarna zdravil d.d. Novo mesto
- 🇺🇸 Jakafi Xr Approved · Incyte Corp
- 🇪🇺 Ruxolitinib Viatris Authorised · Viatris Limited
- 🇪🇺 Jakavi Authorised · Novartis Europharm Limited
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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.