NovoSeven

RSS

eptacog alfa (activated)

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

Overview

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).

This EPAR was last updated on 16/01/2017

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
31
Date of issue of marketing authorisation valid throughout the European Union
23/02/1996
Contact address
Novo Allé
DK-2880 Bagsværd
Denmark

Product information

08/12/2016 NovoSeven - EMEA/H/C/000074 - II/0092

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.

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

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