Coagadex

RSS

human coagulation factor X

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

Overview

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

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

This EPAR was last updated on 04/04/2016

Authorisation details

Product details
Name
Coagadex
Agency product number
EMEA/H/C/003855
Active substance
Human coagulation factor X
International non-proprietary name (INN) or common name
human coagulation factor X
Therapeutic area (MeSH)
Factor X Deficiency
Anatomical therapeutic chemical (ATC) code
B02BD13
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.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Bio Products Laboratory Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
16/03/2016
Contact address
Dagger Lane
Elstree
Hertfordshire WD6 3BX
United Kingdom

Product information

16/03/2016 Coagadex - EMEA/H/C/003855 - -

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

Powder and solvent for solution for injection

Therapeutic indication

Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency.

Assessment history

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