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DAWNZERA Otsuka Australia Pharmaceutical Pty Ltd
Product name
DAWNZERA
Accepted date
Jul-2025
Active ingredients
donidalorsen
Proposed indication
Dawnzera (donidalorsen) is proposed to prevent recurrent, sudden, and potentially life-threatening swelling of tissues in the body in people with hereditary angioedema (HAE). It is intended to treat adults and teens aged 12 and older.
Application type
A (new medicine)
Publication date
Jul-2025
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.