Phosphates

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 phosphates. It includes information for the package leaflet and needs to be read in conjunction with questions and answers.

Current effective version

Information for the package leaflet regarding phosphates used as excipients in eye drops

AdoptedReference Number: EMA/CHMP/632775/2016

Questions and answers on the use of phosphates in eye drops

Reference Number: EMA/CHMP/753373/2012Summary:

The European Medicines Agency has completed an assessment of the use of phosphate buffers in medicinal products given as eye drops and whether these can cause corneal calcification (build-up of calcium deposits in the cornea, the clear layer at the front of the eye).