Medicine guide

Cevenfacta

·

  • Prescription status not stated
  • Blood, clotting and anaemia
Active substance
Eptacog beta (activated)
Made by
Laboratoire Francais du Fractionnement et des Biotechnologies

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

  • 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.

From the official label · 2026-09-30 · European Medicines Agency

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

SpainNo exact match for this strength and form

CanadaNo exact match for this strength and form

NetherlandsNo exact match for this strength and form

SwitzerlandNo exact match for this strength and form

Details

Made byLaboratoire Francais du Fractionnement et des Biotechnologies
Active substanceEptacog beta (activated)
Used inBlood, clotting and anaemia
ClassificationB02BD08 · Blood, clotting and anaemia
Additional monitoring ▼Yes — under additional monitoring (black triangle). Report suspected side effects.
Authorised on2022-07-15
Last updated by the regulator2022-11-29
EMA product numberEMEA/H/C/005655

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).