Boric acid and borates
Table of contents
| Keywords | Excipients, package leaflet, boric acid, borates, boron, borax |
| Description | This document supports the revision of the annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to boric acid. It includes new information for the package leaflet and needs to be read in conjunction with the background review. |
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Questions and answers on boric acid and borates used as excipients in medicinal products for human use (PDF/156.48 KB)
Adopted
First published: 09/10/2017
Last updated: 09/10/2017
EMA/CHMP/619104/2013 -
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Overview of comments received on the draft 'Questions and answers on boric acid’ (PDF/210.95 KB)
First published: 09/10/2017
Last updated: 09/10/2017
EMA/CHMP/735217/2015 -
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Draft questions and answers on boric acid in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (PDF/126.32 KB)
Draft: consultation closed
First published: 04/08/2015
Last updated: 04/08/2015
Consultation dates: 04/08/2015 to 03/11/2015
EMA/CHMP/619104/2013 -
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Boric acid and borate used as excipients - Report published in support of the ‘Questions and answers on boric acid and borates used as excipients in medicinal products for human use’ (PDF/375.17 KB)
First published: 09/10/2017
Last updated: 09/10/2017
EMA/CHMP/765436/2012 -
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Background review for the excipient boric acid: In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ - Draft report (PDF/617.57 KB)
Draft
First published: 04/08/2015
Last updated: 04/08/2015
EMA/CHMP/765436/2012