Tradename: COAGADEX

Proper Name: Coagulation Factor X, (human)    

Indication: To expand the indication for perioperative management of bleeding to include patients with severe hereditary Factor X deficiency based on submission of the final study report for Study TEN06, intended to fulfill the Postmarketing Commitment      

Indicated in adults and children with hereditary Factor X deficiency for:

Routine prophylaxis to reduce the frequency of bleeding episodes

On-demand treatment and control of bleeding episodes

Perioperative management of bleeding in patients with mild, moderate and severe hereditary Factor X deficiency


Approval Date: 04/14/2023

Manufacturer: Bio Products Laboratory Limited