NovoEight

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turoctocog alfa

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

Overview

An overview of NovoEight and why it is authorised in the EU

NovoEight is a medicine used to treat and prevent bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). NovoEight is intended for either short-term or long-term use.

The medicine contains the active substance turoctocog alfa.

This EPAR was last updated on 07/08/2018

Authorisation details

Product details
Name
NovoEight
Agency product number
EMEA/H/C/002719
Active substance
turoctocog alfa
International non-proprietary name (INN) or common name
turoctocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02BD02
Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
13/11/2013
Contact address
Novo Alle
Bagsværd - 2880
Denmark

Product information

30/07/2018 NovoEight - EMEA/H/C/002719 - R/0025

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

coagulation factor VIII

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.

Assessment history

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