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.
NovoEight : EPAR - Medicine overview (PDF/76.39 KB)
First published: 09/12/2013
Last updated: 07/08/2018
NovoEight : EPAR - Risk-management-plan summary (PDF/84.06 KB) (updated)
First published: 07/08/2018
Last updated: 06/01/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novo Nordisk A/S
|Date of issue of marketing authorisation valid throughout the European Union||
31/10/2019 NovoEight - EMEA/H/C/002719 - II/0030/G
- 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.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.