Lanreotide acetate product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of lanreotide acetate.
Keywords: Bioequivalence, generics, lanreotide acetate
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
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Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg productspecific bioequivalence guidance (PDF/173.79 KB)
Adopted
First published: 16/12/2022
Legal effective date: 01/07/2023
EMA/CHMP/559891/2021 -
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Overview of comments on 'Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance' (PDF/163.59 KB)
First published: 16/12/2022
EMA/CHMP/839131/2022 -
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Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance (PDF/144.16 KB)
Draft: consultation closed
First published: 17/05/2022
Consultation dates: 17/05/2022 to 31/08/2022
EMA/CHMP/559891/2021