Nuwiq
simoctocog alfa
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Nuwiq. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Nuwiq.
For practical information about using Nuwiq, patients should read the package leaflet or contact their doctor or pharmacist.
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Nuwiq : EPAR - Summary for the public (PDF/76.54 KB)
First published: 19/12/2014
Last updated: 17/01/2018 -
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Nuwiq : EPAR - Risk-management-plan summary (PDF/57.09 KB)
First published: 19/12/2014
Last updated: 19/12/2014
Authorisation details
Product details | |
---|---|
Name |
Nuwiq
|
Agency product number |
EMEA/H/C/002813
|
Active substance |
simoctocog alfa
|
International non-proprietary name (INN) or common name |
simoctocog alfa
|
Therapeutic area (MeSH) |
Hemophilia A
|
Anatomical therapeutic chemical (ATC) code |
B02BD02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Octapharma AB
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
22/07/2014
|
Contact address |
Product information
25/07/2019 Nuwiq - EMEA/H/C/002813 - WS/1506/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
Therapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Nuwiq can be used for all age groups.