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.
The medicine contains the active substance turoctocog alfa
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List item
NovoEight : EPAR - Medicine overview (PDF/119.71 KB)
First published: 09/12/2013
Last updated: 29/01/2020 -
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List item
NovoEight : EPAR - Risk-management-plan summary (PDF/300.78 KB)
First published: 07/08/2018
Last updated: 19/05/2021
Authorisation details
Product details | |
---|---|
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
|
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 |
13
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Date of issue of marketing authorisation valid throughout the European Union |
13/11/2013
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Contact address |
Novo Alle |
Product information
01/10/2020 NovoEight - EMEA/H/C/002719 - II/0035
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.