Coagadex

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human coagulation factor X

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

Overview

Coagadex is a medicine used for the treatment and prevention of bleeding (including during and after an operation) in patients with hereditary factor X deficiency. Factor X deficiency is a bleeding disorder caused by lack of factor X, a protein needed for normal clotting of the blood.

Factor X deficiency is rare and Coagadex was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 14 September 2007. Further information on the orphan designation can be found on EU/3/07/471 page.

Coagadex contains the active substance human coagulation factor X.

This EPAR was last updated on 08/04/2019

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
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Additional monitoringAdditional 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.

OrphanOrphan

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
BPL Bioproducts Laboratory GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
16/03/2016
Contact address

BPL Bioproducts Laboratory GmbH
Dornhofstrasse
63263 Neu-Isenburg
Germany

Product information

28/03/2019 Coagadex - EMEA/H/C/003855 - T/0014

Contents

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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. Coagadex is indicated in all age groups.

Assessment history

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