Clinical investigation of plasma-derived antithrombin products - Scientific guideline

This document summarises the clinical trials required for authorisation of new and modified human plasma derived antithrombin products.

Keywords: Congenital antithombin deficiency, acquired antithombin deficiency

Current effective version

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

AdoptedLegal effective date: 01/07/2002Reference Number: CPMP/BPWG/2220/99

English (EN) (168.36 KB - PDF)

First published: 17/01/2002Last updated: 17/01/2002