Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg.

Keywords: Bioequivalence, generics, budesonide

 

Current version

Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/219393/2024 Legal effective date: 01/09/2025

Document history

Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 25/06/2024 to 30/09/2024 Reference Number: EMA/CHMP/219393/2024 Summary:

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