Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1

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Document details

Download document Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1
Reference number EMEA/CHMP/BMWP/31329/2005
Status draft: consultation open
First published 2018-08-15
Last updated 2018-08-15
Consultation start date 2018-08-15
Consultation end date 2019-02-15
Email address for submissions bmwp.secretariat@ema.europa.eu

Summary

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005