Nemluvio (nemolizumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- nemolizumab
- Company
- Galderma International
- Status
- Authorised
- Therapeutic area
- Dermatitis, Atopic; Prurigo
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Wed 12 Feb 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006149
- ATC
- D11AH12
- Official record
- www.ema.europa.eu
Indication
Atopic dermatitis (AD) Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. Prurigo nodularis (PN) Nemluvio is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
Regulatory milestones
No milestones recorded in the last year.
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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.