Eptacog beta (activated)

This medicine is authorised for use in the European Union.


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).

This EPAR was last updated on 29/11/2022

Authorisation details

Product details
Agency product number
Active substance
Eptacog beta (activated)
International non-proprietary name (INN) or common name
Eptacog beta (activated)
Therapeutic area (MeSH)
  • Hemophilia A
  • Hemophilia B
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Laboratoire Francais du Fractionnement et des Biotechnologies
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Tour W
102 Terrasse Boieldieu
92800 Puteaux

Product information

19/05/2022 Cevenfacta - EMEA/H/C/005655 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


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.

Assessment history

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