Eudralex Volume 3 Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product CHMP/QWP/396951/06
Titel:
Eudralex Volume 3 Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product CHMP/QWP/396951/06
Kurztitel:
CHMP/QWP/396951/06
Internet:
Herkunft/Verlag:
EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Dokumentenart:
Leitlinie
Inhalt:
This guideline describes the information that needs to be submitted in relation to excipients including antioxidants and antimicrobial preservatives, in the context of applications for marketing authorisations or variations relating to an excipient in authorised medicinal products.