Adynovi
rurioctocog alfa pegol
Table of contents
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.
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 | |
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Marketing-authorisation holder |
Baxalta Innovations GmbH
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
08/01/2018
|
Contact address |
Product information
17/01/2019 Adynovi - EMEA/H/C/004195 - II/0003
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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).