COAGADEX Regulatory Services Australia
Product name
COAGADEX
Sponsor
Accepted date
Jul-2026
Active ingredients
Factor X
Summary of proposed indication
COAGADEX (Factor X) is proposed for use in people with hereditary factor X deficiency. Factor X is a blood-clotting protein that helps stop bleeding. COAGADEX is intended to help prevent bleeding episodes and manage bleeding during and around surgery. It is proposed for use in people of all ages.
Application type
A (new medicine)
Publication date
Jul-2026
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.