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

Related Information

• C1 Esterase Inhibitor
• CBER-Regulated Products with Supporting Documents