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

HumanScientific guidelines

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

Adopted Reference Number: EMA/CHMP/219288/2024 Legal effective date:

English (EN) (141.73 KB - PDF)

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Document history

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

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/219288/2024 Summary:

Comments should be provided using this EUSurvey form . For any technical issues, please contact the EUSurvey Support.

English (EN) (178.77 KB - PDF)

First published:
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