Allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations - Scientific guideline

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This document provides guidance on the clinical development  for allergen products for immunotherapy and allergy diagnosis in moderate to low-sized study populations.

Keywords: Allergen, allergy, allergen immunotherapy, immune therapy, small population

Current version

Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to lowsized study populations

Adopted Reference Number: EMA/161669/2025 Legal effective date:

English (EN) (389.63 KB - PDF)

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Overview of comments received on "Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations"

Reference Number: (EMA/CHMP/72790/2024)

English (EN) (165.69 KB - PDF)

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Document history

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/72790/2024

English (EN) (408.45 KB - PDF)

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