Note for guidance on the clinical investigation of plasma derived antithrombin products

We have adopted this International Scientific Guideline - CPMP/BPWG/2220/99

Last updated

17 January 2025

About this guideline

Overseas effective date: July 2002

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

TGA annotations:

If a sponsor believes that the patient numbers specified in this guideline are not achievable in Australia, advice should be sought from the TGA.

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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