Colchicine product-specific bioequivalence guidance

This document provides product-specific guidance on colchicine.

Keywords: Bioequivalence, generics, colchicine

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current version - effective 1 January 2026

Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/188361/2025 Rev. 1 Legal effective date: 01/01/2026

Document history

Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/35552/2019 Legal effective date: 01/04/2020

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 08/03/2019 to 30/06/2019 Reference Number: EMA/CHMP/35552/2019