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Guideline on clinical investigation of recombinant and human plasma-derived factor IX products

We have adopted this International Scientific Guideline - EMA/CHMP/BPWP/144552/2009 Rev. 1, Corr. 1. 

Last updated

About this guideline

Overseas effective date: 1 September 2015

Replaces: EMA/CHMP/BPWP/144552/2009 Guideline on clinical investigation of recombinant and human plasma-derived factor IX products (Adopted by TGA 1 June 2014)

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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