NovoSeven

eptacog alfa (activated)

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About

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is NovoSeven?

NovoSeven is a powder and solvent that are made up into a solution for injection. It contains the active substance eptacog alfa.

What is NovoSeven used for?

NovoSeven is used for the treatment and prevention of bleeding connected with surgery in the following groups of patients:

  • patients with congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop ‘inhibitors’ (antibodies) against factor VIII or IX;
  • patients with acquired haemophilia (a disease caused by the spontaneous development of inhibitors to factor VIII);
  • patients with congenital factor-VII deficiency;
  • patients with Glanzmann’s thrombasthenia (a rare bleeding disorder) who cannot be treated with a transfusion of platelets (components that help the blood to clot).

The medicine can only be obtained with a prescription.

How is NovoSeven used?

Treatment with NovoSeven should be started under the supervision of a doctor who has experience in the treatment of haemophilia or bleeding disorders. NovoSeven is given by injection into a vein.

  • In haemophilia, the dose is 90 micrograms per kilogram body weight, repeated every two to three hours until the bleeding is controlled. A higher dose may be needed in children. A single dose of 270 micrograms/kg may be used in adults with a mild or moderate bleeding episode.
  • In factor VII deficiency, the dose is 15 to 30 micrograms/kg every four to six hours until the bleeding is controlled.
  • In Glanzmann’s thrombasthenia, the dose is 90 micrograms/kg every two hours, for a minimum of three doses.

Patients or carers may be able to give NovoSeven themselves after suitable training. See the package leaflet for the full dosing details in all uses.

How does NovoSeven work?

The active substance in NovoSeven, eptacog alfa (activated), is almost identical to a human protein called factor VII. Eptacog alfa works in the same way as factor VII. In the body, factor VII is involved in blood clotting. It activates another factor called factor X, which starts the clotting process. By activating factor X, NovoSeven is able to give temporary control of the bleeding disorder.

Because factor VII acts directly on factor X, independently from factors VIII and IX, NovoSeven can be used in haemophilia patients who have developed inhibitors to factor VIII or IX. NovoSeven can also be used to replace the missing factor VII in patients with factor VII deficiency.

Eptacog alfa is not extracted from human blood but is produced by a method known as ‘recombinant DNA technology: it is made by cells that have received a gene (DNA), which makes them able to produce eptacog alfa.

How has NovoSeven been studied?

NovoSeven has been studied in patients with haemophilia and in patients with factor VII deficiency. The main measure of effectiveness was the number of bleeding episodes that were controlled effectively. To find out whether the medicine could be used in the home setting, the company carried out studies in 60 patients with mild to moderate bleeding episodes. NovoSeven has also been studied in patients with Glanzmann’s thrombasthenia who could not be treated with platelets.

What benefit has NovoSeven shown during the studies?

In the largest study, which included 61 haemophilia patients with inhibitors, 84% of the 57 serious bleeds and 59% of the 38 surgical bleeds were controlled effectively with NovoSeven.

In the study in which NovoSeven was given in the home setting, 90% of the bleeding episodes were controlled effectively.

In the study of Glanzmann’s thrombasthenia, treatment with NovoSeven was successful in 74% of the bleeds (42 out of 57).

What is the risk associated with NovoSeven?

Side effects with NovoSeven are not common. However the following side effects are seen in between 1 and 10 patients in 1,000: venous thromboembolic events (problems caused by blood clots in the veins), rash, pruritus (itching), urticaria (hives), decreased therapeutic response (lack of effectiveness of treatment) and pyrexia (fever). For the full list of all side effects reported with NovoSeven, see the package leaflet.

NovoSeven must not be used in people who are hypersensitive (allergic) to eptacog alfa, to mouse, hamster or cow proteins, or to any of the other ingredients.

Why has NovoSeven been approved?

The CHMP decided that NovoSeven’s benefits are greater than its risks for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in patients with congenital haemophilia, acquired haemophilia, congenital factor VII deficiency or Glanzmann’s thrombasthenia. The Committee recommended that NovoSeven be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of NovoSeven?

A risk management plan has been developed to ensure that NovoSeven is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NovoSeven, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about NovoSeven

The European Commission granted a marketing authorisation valid throughout the European Union for NovoSeven on 23 February 1996.

For more information about treatment with NovoSeven, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
NovoSeven : EPAR - Summary for the public BG = bălgarski 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public ES = español 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public CS = čeština 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public DA = dansk 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public DE = Deutsch 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public ET = eesti keel 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public EL = elliniká 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public EN = English 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public FR = français 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public IT = italiano 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public LV = latviešu valoda 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public LT = lietuvių kalba 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public HU = magyar 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public MT = Malti 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public NL = Nederlands 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public PL = polski 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public PT = português 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public RO = română 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public SK = slovenčina 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public SL = slovenščina 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public FI = suomi 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public SV = svenska 18/06/2009 01/04/2016
NovoSeven : EPAR - Summary for the public HR = Hrvatski 18/06/2009 01/04/2016

This EPAR was last updated on 01/04/2016 .

Authorisation details

Product details

Product details for NovoSeven
NameNovoSeven
Agency product numberEMEA/H/C/000074
Active substance

eptacog alfa (activated)

International non-proprietary name (INN) or common name

eptacog alfa (activated)

Therapeutic area Hemophilia BThrombastheniaFactor VII DeficiencyHemophilia A
Anatomical therapeutic chemical (ATC) code B02BD08

Publication details

Publication details for NovoSeven
Marketing-authorisation holder

Novo Nordisk A/S

Revision30
Date of issue of marketing authorisation valid throughout the European Union23/02/1996

Contact address:

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Product information

Product information

21/01/2016  NovoSeven -EMEA/H/C/000074 -II/0090/G

Name Language First published Last updated
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016
NovoSeven : EPAR - Product Information HR = Hrvatski 14/07/2009 01/04/2016

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016
NovoSeven : EPAR - All Authorised presentations HR = Hrvatski 07/05/2008 01/04/2016

Name Language First published Last updated
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  
NovoSeven : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 07/05/2008  

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
NovoSeven : EPAR - Procedural steps taken before authorisation HR = Hrvatski 21/10/2005  
NovoSeven : EPAR - Scientific Discussion HR = Hrvatski 21/10/2005  

Authorised

This medicine is approved for use in the European Union

Related information

More information on NovoSeven