Adynovi

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rurioctocog alfa pegol

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

Overview

This is a summary of the European public assessment report (EPAR) for Adynovi. 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 Adynovi.

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

This EPAR was last updated on 09/04/2018

Authorisation details

Product details
Name
Adynovi
Agency product number
EMEA/H/C/004195
Active substance
rurioctocog alfa pegol
International non-proprietary name (INN) or common name
rurioctocog alfa pegol
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
Baxalta Innovations GmbH
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
08/01/2018
Contact address
Industriestrasse 67
A-1221 Vienna
Austria

Product information

12/03/2018 Adynovi - EMEA/H/C/004195 - IB/0001

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

ANTIHEMORRHAGICS
 

Therapeutic indication

Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).

Assessment history

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