Garadacimab
Drugs Used In Hereditary Angioedema
Sold as ANDEMBRY
- Drug class
- Drugs Used In Hereditary Angioedema
- Availability
- Prescription only
- Routes
- Subcutaneous
- Markets covered
- 4
- Products on record
- 6
- FDA reports (12 mo)
- 270
Overview
Garadacimab is an active pharmaceutical ingredient in the Drugs Used In Hereditary Angioedema group (B06AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 2 | March 27, 2026 |
| CA Canada | Health Canada | 2 | January 16, 2026 |
| US United States | FDA | 1 | June 30, 2025 |
| EU European Union | EMA | 1 | March 11, 2025 |
GBUnited Kingdom· MHRA
2 products
Uses
ANDEMBRY is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
How to take
CACanada· Health Canada
2 products
Uses
ANDEMBRY (garadacimab injection) is indicated for routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients (aged 12 years and older). ANDEMBRY is not intended for acute treatment of HAE attacks. 1 Pediatrics Adolescents (≥ 12 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ANDEMBRY in pediatric patients age 12 years and older has been established.
Therefore, Health Canada has authorized an indication for pediatric use above 12 years age group (see 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment).
Pediatrics (<12 years):
The safety and efficacy of ANDEMBRY in pediatric patients below the age of 12 have not been established. 4 Geriatrics). No overall differences in safety or efficacy were observed compared to patients 18 to 65 years of age.
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
( 1 )
How to take
EUEuropean Union· EMA
1 product
Uses
ANDEMBRY is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
How to take
Sources & citations
- [1]MHRA (UK) · PLGB150360161 · revised March 27, 2026
- [2]Health Canada (DPD) · 02559765 · revised October 31, 2025
- [3]FDA DailyMed · 07b0b671-db81-49… · revised June 30, 2025 [PDF]
- [4]European Medicines Agency · EMEA/H/C/006116 · revised March 11, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.