BERINERT SC (CSL Behring Australia Pty Ltd)
Product name
BERINERT SC
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
171 working days (255)
Active ingredients
C1 esterase inhibitor
Registration type
EOI
Indication
BERINERT SC (subcutaneous injection) is now also indicated for prevention of recurrent Hereditary Angioedema (HAE) attacks in adolescent and adult patients with C1 esterase inhibitor deficiency.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.