HAEGARDA
STN: BL 125606
Proper Name: C1 Esterase Inhibitor (Human)
Tradename: Haergada
Manufacturer: CSL Behring GmbH
Indication:
- For the routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.
Product Information
- Package Insert - HAEGARDA
- Demographic Subgroup Information - C1 Esterase Inhibitor Subcutaneous (Human) [HAEGARDA]
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- Clinical Review - HAEGARDA
- Statistical Review - HAEGARDA
- September 24, 2020 Approval Letter - HAEGARDA
- Approval History, Letters, Reviews, and Related Documents - HAEGARDA
- Supporting Documents older than three years - HAEGARDA