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Guideline on the clinical investigation of Plasma derived Fibrin Sealant/Haemostatic Products

We have adopted this International Scientific Guideline - CPMP/BPWG/1089/00 

Last updated

About this guideline

Overseas effective date:  1 January 2005

Replaces: Concept paper on the need for revision of the guideline on the clinical investigation of plasma derived fibrin sealant/haemostatic products (CPMP/BPWG/1089/00) and the related Core SmPC (CPMP/BPWG/153/00) [EMA/CHMP/BPWP/572810/2013].

Categories: Clinical efficacy and safety | Blood products (including biotech alternatives)

TGA Annotations: Nil

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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For more information see International scientific guidelines adopted in Australia.

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