Propylene glycol and esters

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 propylene glycol and esters. It includes new information for the package leaflet and needs to be read in conjunction with the background scientific review. Keywords: Excipients, package leaflet, propylene glycol, esters of propylene glycol

Current effective version

Questions and answers on propylene glycol used as an excipient in medicinal products for human use

AdoptedReference Number: EMA/CHMP/704195/2013

Document history

Overview of comments received on the draft 'Questions & answers on propylene glycol and esters'

Reference Number: EMA/CHMP/157147/2015

Draft questions and answers on propylene glycol and esters 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: 01/12/2014 to 28/02/2015Draft: consultation closedReference Number: EMA/CHMP/704195/2013Summary:

Following the European Commission decision to revise the Annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), a multidisciplinary group of experts was created in 2011 to update the labelling of selected excipients listed in the annex of the guideline and to add new excipients to the list, based on a review of their safety. Draft Q&A documents on excipients are progressively released for public consultation. They include proposals for new or updated information for the labelling and package leaflet. A corresponding background report supporting the review is published for information only.

Propylene glycol used as an excipient - Report published in support of the ‘Questions and answers on propylene glycol used as an excipient in medicinal products for human use’

Reference Number: EMA/CHMP/334655/2013

Background review for the excipient propylene glycol: 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

Reference Number: EMA/CHMP/334655/2013