Boric acid and borates

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.

Keywords: Excipients, package leaflet, boric acid, borates, boron, borax

Current version

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’ - Rev. 1

Reference Number: EMA/CHMP/765436/2012 Rev.1

Questions and answers on boric acid and borates used as excipients in medicinal products for human use - Rev.1

AdoptedReference Number: EMA/CHMP/619104/2013 Rev.1

Document history - First version

Questions and answers on boric acid and borates used as excipients in medicinal products for human use

AdoptedReference Number: EMA/CHMP/619104/2013

Overview of comments received on the draft 'Questions and answers on boric acid’

Reference Number: EMA/CHMP/735217/2015

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’

Consultation dates: 04/08/2015 to 03/11/2015Draft: consultation closedReference Number: EMA/CHMP/619104/2013Summary:

The objective of this group is to update the labelling of selected excipients listed in the Annex of the above mentioned European Commission (EC) guideline, as well as to add new excipients to the list, based on a review of their safety. The main safety aspects to be addressed were summarised in a concept paper published in March 2012.

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’

Reference Number: EMA/CHMP/765436/2012

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

DraftReference Number: EMA/CHMP/765436/2012