NovoEight
turoctocog alfa
Table of contents
Overview
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.
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NovoEight : EPAR - Medicine overview (PDF/76.39 KB)
First published: 09/12/2013
Last updated: 07/08/2018 -
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NovoEight : EPAR - Risk-management-plan summary (PDF/112.11 KB)
First published: 07/08/2018
Last updated: 07/08/2018
This EPAR was last updated on 22/08/2019
Authorisation details
Product details | |
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Name |
NovoEight
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Agency product number |
EMEA/H/C/002719
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Active substance |
turoctocog alfa
|
International non-proprietary name (INN) or common name |
turoctocog alfa
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Therapeutic area (MeSH) |
Hemophilia A
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Anatomical therapeutic chemical (ATC) code |
B02BD02
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Publication details | |
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Marketing-authorisation holder |
Novo Nordisk A/S
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Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
13/11/2013
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Contact address |
Product information
22/11/2018 NovoEight - EMEA/H/C/002719 - II/0026/G
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
Pharmacotherapeutic group
coagulation factor VIII
Therapeutic indication
Therapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.