Budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 mg product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of budesonide, gastro-resistant hard capsules, 3 mg, gastro-resistant granules, 9 mg product-specific bioequivalence guidance.

Keywords: Bioequivalence, generics, budesonide

 

Current version

Budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/219288/2024Legal effective date: 01/09/2025

Document history

Budesonide, gastro-resistant hard capsules, 3 mg, gastro-resistant granules, 9 mg product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 25/06/2024 to 30/09/2024Reference Number: EMA/CHMP/219288/2024Summary:

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