Coagadex
human coagulation factor X
Table of contents
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.
Authorisation details
Product details | |
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Name |
Coagadex
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Agency product number |
EMEA/H/C/003855
|
Active substance |
Human coagulation factor X
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International non-proprietary name (INN) or common name |
human coagulation factor X
|
Therapeutic area (MeSH) |
Factor X Deficiency
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Anatomical therapeutic chemical (ATC) code |
B02BD13
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Accelerated 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 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 | |
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Marketing-authorisation holder |
BPL Bioproducts Laboratory GmbH
|
Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
16/03/2016
|
Contact address |
Product information
13/01/2021 Coagadex - EMEA/H/C/003855 - IAIN/0036/G
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
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Pharmacotherapeutic group
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Vitamin K and other hemostatics
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Antihemorrhagics
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coagulation factor X
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.