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.
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Coagadex : EPAR - Medicine overview (PDF/76.9 KB)
First published: 04/04/2016
Last updated: 07/11/2018 -
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Coagadex : EPAR - Risk-management-plan summary (PDF/126.84 KB)
First published: 09/04/2021
Authorisation details
Product details | |
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Name |
Coagadex
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Agency product number |
EMEA/H/C/003855
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Active substance |
Human coagulation factor X
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International non-proprietary name (INN) or common name |
human coagulation factor X
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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. |
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
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Revision |
9
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Date of issue of marketing authorisation valid throughout the European Union |
16/03/2016
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Contact address |
BPL Bioproducts Laboratory GmbH |
Product information
17/01/2023 Coagadex - EMEA/H/C/003855 - N/0049
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.