Etonogestrel and ethinylestradiol vaginal delivery system product-specific bioequivalence

This document provides product-specific guidance on the demonstration of the etonogestrel and ethinylestradiol vaginal delivery system 0.12mg/0.015mg/day.

Keywords: Bioequivalence, etonogestrel, ethinylestradiol

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

Etonogestrel and ethinylestradiol vaginal delivery system 0.12 mg/0.015 mg/day product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/97470/2019 Legal effective date: 01/09/2020

Document history

Draft etonogestrel and ethinylestradiol vaginal delivery system 0.12mg/0.015mg/day product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 27/05/2019 to 28/10/2019 Reference Number: EMA/CHMP/97470/2019 Summary:

This document provides product-specific guidance on the demonstration of the etonogestrel and ethinylestradiol vaginal delivery system 0.12mg/0.015mg/day.