Advate
octocog alfa
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Advate. 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 Advate. For practical information about using Advate, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
Product details | |
---|---|
Name |
Advate
|
Agency product number |
EMEA/H/C/000520
|
Active substance |
octocog alfa
|
International non-proprietary name (INN) or common name |
octocog alfa
|
Therapeutic area (MeSH) |
Hemophilia A
|
Anatomical therapeutic chemical (ATC) code |
B02BD02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Takeda Manufacturing Austria AG
|
Revision |
31
|
Date of issue of marketing authorisation valid throughout the European Union |
02/03/2004
|
Contact address |
Industriestrasse 67 |
Product information
04/07/2022 Advate - EMEA/H/C/000520 - IB/0117
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
Antihemorrhagics
Therapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).
Advate does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand disease.