Basic Information
Cevenfacta
Regulatory Information
EMEA/H/C/005655
July 15, 2022
May 19, 2022
November 29, 2022
Company Information
France
Tour W 102 Terrasse Boieldieu 92800 Puteaux
LABORATOIRE FRANCAIS DU FRACTIONNEMENT ET DES BIOTECHNOLOGIES
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: - in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ?5 Bethesda Units (BU)); - in patients with congenital haemophilia with low titre inhibitors (BU <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX.
Overview Summary
Cevenfacta is a medicine used to treat bleeding episodes and to prevent bleeding in patients undergoing surgery. It is used in adults and adolescents aged 12 years or older with inherited haemophilia who have developed or are expected to develop inhibitors (antibodies) against coagulation factors VIII or IX (proteins involved in blood clotting), or who are unlikely to respond to treatment with these coagulation factors. Cevenfacta contains the active substance eptacog beta (activated).