NovoSeven

RSS

eptacog alfa (activated)

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 23/01/2019

Authorisation details

Product details
Name
NovoSeven
Agency product number
EMEA/H/C/000074
Active substance
eptacog alfa (activated)
International non-proprietary name (INN) or common name
eptacog alfa (activated)
Therapeutic area (MeSH)
  • Hemophilia B
  • Thrombasthenia
  • Factor VII Deficiency
  • Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02BD08
Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
23/02/1996
Contact address
Novo Allé
DK-2880 Bagsværd
Denmark

Product information

20/11/2018 NovoSeven - EMEA/H/C/000074 - II/0104

Contents

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Pharmacotherapeutic group

Antihaemorrhagics

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.

 

Assessment history

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