Clinical investigation of medicinal products in the treatment of epileptic disorders - Scientific guideline

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Guidance on the development of medicinal products for the treatment of epileptic disorders.

Keywords: Epilepsy, seizures, anti-epileptic agents

Current version

Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3

Adopted Reference Number: CHMP/EWP/566/98 Rev.3 Legal effective date:

English (EN) (864.29 KB - PDF)

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Document history - Revision 3

Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3

Adopted Reference Number: CHMP/EWP/566/98 Rev.3 Legal effective date:

English (EN) (864.29 KB - PDF)

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Overview of comments received on guideline on clinical investigation of medicinal products in the treatment of epileptic disorders (CHMP/EWP/566/98 Rev.3)

Reference Number: EMA/117925/2025

English (EN) (247.2 KB - PDF)

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Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3

Draft: consultation closed Consultation dates: to Reference Number: CHMP/EWP/566/98 Rev. 3

English (EN) (997.26 KB - PDF)

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Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 2

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/179692/2016

English (EN) (109.97 KB - PDF)

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Document history - Revision 2

Overview of comments received on 'Guideline on Clinical Investigation of Medicinal Products in the treatment of epileptic disorders' (CHMP/EWP/566/98 Rev.2) - Revision 2

Reference Number: EMA/611366/2009

English (EN) (127.27 KB - PDF)

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Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 2

Draft: consultation closed Reference Number: CHMP/EWP/566/98 Rev. 2

English (EN) (200.42 KB - PDF)

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Recommendation of revision of the note for guidance on clinical investigation of medicinal products in treatment of epileptic disorders (CPMP/EWP/566/98 Rev. 1) - Revision 2

Reference Number: EMEA/CHMP/EWP/453780/2007

English (EN) (30.87 KB - PDF)

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