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
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.
English (EN) (123.66 KB - PDF)
Document history - First version (current)
Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders
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.
English (EN) (123.66 KB - PDF)
Overview of comments received on paediatric addendum to CHMP guidance on clinical investigation of medicinal products in the treatment of lipid disorders
English (EN) (124.47 KB - PDF)
Draft paediatric addendum to CHMP note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders
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.
English (EN) (143.05 KB - PDF)
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
English (EN) (56.45 KB - PDF)
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