NovoSeven
eptacog alfa (activated)
Table of contents
Overview
NovoSeven is a medicine used to treat and to prevent bleeding after surgical procedures. It is used in patients with the following conditions:
- congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop ‘inhibitors’ (antibodies) against factor VIII or IX;
- acquired haemophilia (a bleeding disease caused by the development of inhibitors to factor VIII);
- congenital factor VII deficiency;
- Glanzmann’s thrombasthenia (a rare bleeding disorder) who cannot be treated with a transfusion of platelets (components that help the blood to clot).
NovoSeven contains the active substance eptacog alfa.
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List item
NovoSeven : EPAR - Medicine overview (PDF/127.56 KB)
First published: 18/06/2009
Last updated: 23/01/2019
EMA/776441/2018 -
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List item
NovoSeven : EPAR - Risk-management-plan summary (PDF/74.98 KB)
First published: 18/12/2018
This EPAR was last updated on 21/11/2019
Authorisation details
Product details | |
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Name |
NovoSeven
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Agency product number |
EMEA/H/C/000074
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Active substance |
eptacog alfa (activated)
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International non-proprietary name (INN) or common name |
eptacog alfa (activated)
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
B02BD08
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Publication details | |
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Marketing-authorisation holder |
Novo Nordisk A/S
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Revision |
33
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Date of issue of marketing authorisation valid throughout the European Union |
23/02/1996
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Contact address |
Product information
17/10/2019 NovoSeven - EMEA/H/C/000074 - II/0106
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antihaemorrhagics
Therapeutic indication
Therapeutic indication
NovoSeven is indicated 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 inhibitors to coagulation factors VIII or IX > 5 Bethesda units (BU);
- in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-VIII or factor-IX administration;
- in patients with acquired haemophilia;
- in patients with congenital factor-VII deficiency;
- in patients with Glanzmann's thrombasthenia with antibodies to platelet glycoprotein (GP) IIb-IIIa and / or human leucocyte antigens (HLA), and with past or present refractoriness to platelet transfusions.
- in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.