Page contentsPage contents Current version - effective 1 January 2026 Document history Related content Topics This document provides product-specific guidance on colchicine. Keywords: Bioequivalence, generics, colchicine Abbreviations: BCS Classification: Biopharmaceutics Classification System AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours Cmax: maximum plasma concentration Current version - effective 1 January 2026 Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance - Revision 1Adopted Reference Number: EMA/188361/2025 Rev. 1 Legal effective date: 01/01/2026 English (EN) (136.42 KB - PDF)First published: 30/07/2025 View Document history Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidanceAdopted Reference Number: EMA/CHMP/35552/2019 Legal effective date: 01/04/2020 English (EN) (125.82 KB - PDF)First published: 15/10/2019 View Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidanceDraft: consultation closed Consultation dates: 08/03/2019 to 30/06/2019 Reference Number: EMA/CHMP/35552/2019 English (EN) (124.21 KB - PDF)First published: 08/03/2019 View Related content Product-specific bioequivalence guidance Topics Scientific guidelines Share this page