Allergen products: production and quality issues

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Current effective version

Adopted guideline

Reference numberCHMP/BWP/304831/07
Effective from20/05/2009
KeywordsAllergen products, homologous groups
DescriptionThis document provides the quality recommendations for allergen products of biological origin. It applies to allergen extracts derived from natural source material and allergens produced through recombinant DNA technology, used for specific immunotherapy or in vivo diagnosis of IgE-mediated allergic diseases.

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

In operation: 20/05/2009–present

Published: 24/07/2008

Published: 19/07/2006

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