|Adopted proposal||Adopted questions and answers|
|Keywords||Excipients, package leaflet, benzalkonium chloride|
|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 benzalkonium chloride. It includes updated information for the package leaflet and needs to be read in conjunction with the background scientific review.|
- Guideline on summary of product characteristics
- EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use
- Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
- Excipients labelling