Cevenfacta
Eptacog beta (activated)
Table of contents
Overview
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).
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List item
Cevenfacta : EPAR - Medicine Overview (PDF/124.07 KB)
First published: 29/11/2022
EMA/351553/2022 -
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List item
Cevenfacta : EPAR - Risk managment plan summary (PDF/112.02 KB)
First published: 29/11/2022
Authorisation details
Product details | |
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Name |
Cevenfacta
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Agency product number |
EMEA/H/C/005655
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Active substance |
Eptacog beta (activated)
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International non-proprietary name (INN) or common name |
Eptacog beta (activated)
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
B02BD08
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Additional 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 | |
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Marketing-authorisation holder |
Laboratoire Francais du Fractionnement et des Biotechnologies
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Date of issue of marketing authorisation valid throughout the European Union |
15/07/2022
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Contact address |
Tour W |
Product information
19/05/2022 Cevenfacta - EMEA/H/C/005655 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Antihemorrhagics
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.