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

HumanScientific guidelines

Polish is available via eTranslation, the European Commission's machine translation service.

Translate to Polish | Important information about machine translation

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:

English (EN) (141.6 KB - PDF)

Opublikowane po raz pierwszy:
Zobacz

Document history

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

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/219393/2024 Summary:

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

English (EN) (178.83 KB - PDF)

Opublikowane po raz pierwszy:
Zobacz

Share this page