Dawnzera (donidalorsen)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- donidalorsen
- Company
- Otsuka Pharmaceutical Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Angioedemas, Hereditary
- CHMP opinion
- Thu 13 Nov 2025
- EU approval
- Mon 19 Jan 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006554
- ATC
- B06AC
- Official record
- www.ema.europa.eu
Indication
Dawnzera is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
Regulatory milestones
Mon 19 Jan 2026🇪🇺 EU approval (EC decision)
Dawnzera (donidalorsen) approved in the EU
Marketing authorisation to Otsuka Pharmaceutical Netherlands B.V.; Additional monitoring · source
Thu 13 Nov 2025🇪🇺 CHMP positive opinion
Dawnzera (donidalorsen): CHMP positive opinion
Otsuka Pharmaceutical Netherlands B.V.; Additional monitoring · source
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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.