Eltrombopag product-specific bioequivalence guidance - Scientific guideline

This document provides product-specific guidance on the demonstration of the bioequivalence of eltrombopag.

Keywords: bioequivalence, generics, eltrombopag

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

Eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and powder for oral suspension 25 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/226445/2025 Legal effective date: 01/10/2026

Document history

Draft eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and powder for oral suspension 25 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 25/09/2025 to 31/12/2025 Reference Number: EMA/226445/2025