Paediatric addendum to the guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Scientific guideline

This document is an addendum to the guideline on clinical investigation of medicinal products in the treatment of lipid disorders. It highlights differences from adult patients with lipid disorders and points out specific paediatric issues.

Keywords: Lipid disorders, paediatric, familial hypercholesterolemia

Current effective version

Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders

Adopted Reference Number: EMA/CHMP/494506/2012 Legal effective date: 20/03/2013 Summary:

This is an addendum to the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (EMA/CPMP/3020/2003). It is not meant as a guidance document on its own but rather highlights differences from adult patients with lipid disorders and points out specific paediatric issues.

Document history - First version (current)

Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders

Adopted Reference Number: EMA/CHMP/494506/2012 Legal effective date: 20/03/2013 Summary:

This is an addendum to the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (EMA/CPMP/3020/2003). It is not meant as a guidance document on its own but rather highlights differences from adult patients with lipid disorders and points out specific paediatric issues.

Overview of comments received on paediatric addendum to CHMP guidance on clinical investigation of medicinal products in the treatment of lipid disorders

Reference Number: EMA/CHMP/638198/2012

Draft paediatric addendum to CHMP note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders

Draft: consultation closed Consultation dates: 24/06/2010 to 31/12/2010 Reference Number: EMA/CHMP/213057/2010 Summary:

This is an addendum to the Note for Guidance on Clinical Investigation of Medicinal products in the Treatment of Lipid Disorders (EMEA/CHMP/EWP/3020/03). It is not meant as a guidance document on its own but rather highlights differences from adult patients with lipid disorders and points out paediatric specific issues.

Concept paper on the need for the development of a paediatric addendum to the chmp note for guidance on the clinical investigation of medicinal products in the treatment of lipid disorders

Reference Number: EMEA/CHMP/EWP/7895/2009