Limitations to the use of ethylene oxide in the manufacture of medicinal products

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Current effective version

Revision 1 - Adopted guideline

Reference numberEMEA/CVMP/271/01 Rev. 1
Published10/03/2016
Effective from01/04/2001
KeywordsEthylene oxide, sterilisation, carcinogenic
DescriptionThis document describes the circumstances where sterilisation with ethylene oxide can be applied.


Document history

Revision 1

Current version

Adopted guideline




Concept paper

In operation: 01/04/2001–present (The revision 1 revises only the cover page of the note for guidance.  None of the text has been changed)


Published: 19/11/2015

First versionAdopted guidelineIn operation: 01/04/2001–present


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