Similar biological medicinal products containing recombinant follicle-stimulating hormone

Current effective version

PDF icon<b>Adopted guideline</b>

Reference numberCHMP/BMWP/671292/2010
Published06/03/2013
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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/09/2013–present


Published: 06/03/2013


Published: 24/11/2011


Published: 06/04/2010


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