Nuwiq

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simoctocog alfa

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

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.

This EPAR was last updated on 06/04/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Octapharma AB
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
21/07/2014
Contact address
Lars Forssells gata
23 112 75 Stockholm
Sweden

Product information

23/03/2018 Nuwiq - EMEA/H/C/002813 - X/0020

Contents

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

Blood coagulation factors

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Nuwiq can be used for all age groups.

Assessment history

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