Ebglyss (lebrikizumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- lebrikizumab
- Company
- Almirall, S.A.
- Status
- Authorised
- Therapeutic area
- Dermatitis, Atopic
- CHMP opinion
- Thu 14 Sep 2023
- EU approval
- Thu 16 Nov 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005894
- ATC
- D11AH10
- Official record
- www.ema.europa.eu
Indication
Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg 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.