Limitations to the use of ethylene oxide in the manufacture of medicinal products
Table of contents
This document describes the circumstances where sterilisation with ethylene oxide can be applied.
Keywords: Ethylene oxide, sterilisation, carcinogenic
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Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products (PDF/25.94 KB)
Adopted
First published: 29/03/2001
Last updated: 29/03/2001
Legal effective date: 01/04/2001
CPMP/QWP/159/01 -
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Concept paper on a proposal to limit the applicability of the CPMP/CVMP Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products to veterinary medicinal products (PDF/77.08 KB)
Adopted
First published: 19/11/2015
Last updated: 19/11/2015
EMA/CHMP/SWP/211900/2015 -
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Superseded revised note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products (PDF/116.44 KB)
Adopted
First published: 10/03/2016
Last updated: 10/03/2016
EMEA/CVMP/271/01 Rev. 1