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This document provides guidance on the clinical evaluation of medicinal products intended for the treatment of chronic immune thrombocytopenia.
Keywords: Chronic primary immune thrombocytopenia, thrombopoietin receptor agonists
Current effective version
Guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia
English (EN) (315.75 KB - PDF)
Document history
Overview of comments received on “Guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia”
English (EN) (310.3 KB - PDF)
Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia
This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic primary immune thrombocytopenia. The purpose of this guidance is to provide a harmonised regulatory approach that will lead to a consistent assessment of products by regulators and set clear standards for industry.
English (EN) (180.98 KB - PDF)
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