Afstyla

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lonoctocog 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 Afstyla. 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 Afstyla.

For practical information about using Afstyla, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 25/07/2022

Authorisation details

Product details
Name
Afstyla
Agency product number
EMEA/H/C/004075
Active substance
lonoctocog alfa
International non-proprietary name (INN) or common name
lonoctocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02BD02
Publication details
Marketing-authorisation holder
CSL Behring GmbH
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
04/01/2017
Contact address
Emil-von-Behring Strasse 76
35041 Marburg
Germany

Product information

10/06/2022 Afstyla - EMEA/H/C/004075 - II/0042

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

Antihemorrhagics

Therapeutic indication

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

Afstyla can be used for all age groups.

Assessment history

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