Similar biological medicinal products containing recombinant follicle-stimulating hormone

Current effective version

PDF icon<b>Adopted guideline</b>

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

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

Related content

How useful was this page?

Add your rating
1 rating