simoctocog alfa

This medicine is authorised for use in the European Union.


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 21/03/2023

Authorisation details

Product details
Agency product number
Active substance
simoctocog alfa
International non-proprietary name (INN) or common name
simoctocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Octapharma AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Lars Forssells gata
23 112 75 Stockholm

Product information

13/10/2022 Nuwiq - EMEA/H/C/002813 - WS2244

Other EU languages available icon 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:

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

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

Changes since initial authorisation of medicine

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