Draft guideline on the use of phthalates as excipients in human medicinal products

  • Email
  • Help

Document details

Download document Draft guideline on the use of phthalates as excipients in human medicinal products
Reference number EMA/CHMP/SWP/362974/2012
Status draft: consultation closed
First published 08/05/2013
Last updated 08/05/2013

Summary

Literature data in animals show that certain phthalates are associated with effects on reproduction and development in relation to their hormonal (anti-androgenic) properties. Currently available human data on the impact of phthalate exposure are limited and therefore the clinical relevance of such findings remains to be established. This guideline provides recommendations on the use of phthalates as excipients in human medicines.