Andembry (garadacimab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- garadacimab
- Company
- CSL Behring GmbH
- Status
- Authorised
- Therapeutic area
- Angioedemas, Hereditary
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Mon 10 Feb 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006116
- ATC
- B06AC07
- Official record
- www.ema.europa.eu
Indication
Andembry is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
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.