Clinical trials with haematopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy - Scientific guideline

This document provides guidance for the evaluation of products used to reduce the risk of infection, caused by neutropenia induced by cytotoxic chemotherapy or by myeloablative therapy preceding bone marrow transplantation.

Keywords: Growth factors, myelosuppressive therapy, myeloablative therapy

Current effective version

Guideline on clinical trials with haemopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy

Adopted Reference Number: EMEA/CPMP/555/95 Rev. 1 Legal effective date: 01/10/2007

Document history

Overview of comments on guideline on clinical trials with haemopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy (CPMP/EWP/555/95 Rev 1)

Reference Number: EMEA/CHMP/EWP/506296/2007

Draft guideline on clinical trials with haemopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy

Draft: consultation closed Reference Number: CPMP/EWP/555/95 Rev 1