Similar biological medicinal products containing recombinant follicle-stimulating hormone

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Current effective version

Adopted guideline

Reference numberCHMP/BMWP/671292/2010
Effective from01/09/2013
KeywordsFollicle stimulating hormone (FSH), similar biological products, comparability, non-clinical studies, clinical studies
DescriptionThis document lays down the non-clinical and clinical requirements for recombinant human follicle stimulating hormone (r-hFSH)-containing medicinal products claiming to be similar to another one already marketed.

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/09/2013–present

Published: 06/03/2013

Published: 24/11/2011

Published: 06/04/2010

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