Clinical investigation of plasma-derived fibrin sealant/haemostatic products

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCPMP/BPWG/1089/00
Effective from01/01/2005
KeywordsHuman fibrinogen, human thrombin, fibrin sealant
DescriptionThis document summarises the clinical trials required for authorisation of new and modified plasma-derived fibrin sealant/haemostatic products.

Document history

Revision 1

In progress

Concept paper Published: 28/05/2014

First version

Current version

Adopted guideline

In operation: 01/01/2005–present

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