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

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


Download document Draft paediatric addendum to CHMP note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/07/WC500094340.pdf

Reference number EMA/CHMP/213057/2010

Status draft: consultation open

First published 08/07/2010

Last updated
Consultation start date 24/06/2010
Consultation end date 31/12/2010

Email address for submissions ildiko.foldesi@ema.europa.eu

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.