Core summary of product characteristics for plasma-derived fibrin sealant/haemostatic products

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Current effective version

Revision 1 - Adopted guideline

Reference numberEMA/CHMP/BPWP/598816/2010 Rev. 1
Published25/06/2015
Effective from01/01/2016
KeywordsFibrin sealant, haemostatics, human fibrinogen, factor XIII, antifibrinolytics, aprotinin, tranexamic acid, human thrombin, sealant, otologic, rhinologic, ophthalmic and vertebral surgery, cerebro-spinal fluid, dura mater, glueing, neurosurgery, treatment of bleeding, vascular surgery, gastrointestinal anastomoses
DescriptionThis document describes the information to be included in the summary of product characteristics for plasma-derived fibrin sealant/haemostatic products.


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Concept paper


Draft guideline

In operation: 01/01/2016–present


Published: 25/06/2015


Published: 28/05/2014


Published: 27/09/2011

First versionAdopted guidelineIn operation: 01/01/2005–01/01/2016


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