EMA 人用药标签和说明书指南 2019.11.22 英文.pdf

22 November 2019 EMA/CHMP/302620/2017 Rev. 1* Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) Excipients and information for the package leaflet Agreed by CHMP Excipients Drafting Group 6 July 20 17 Adopted by EMA Committee for Medicinal Products for Human Use (CHMP) 20 July 2017 Endorsed by European Commissions Notice to Applicants Group 4 October 2017 Date of publication 22 November 2019 This document replaces the Annex previously included in the Guideline CPMP/463/00 Rev. 1. It is an integral part of the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668). Keywords Excipient, Package Leaflet, Labelling *Rev. 1 includes an update of ethanol. Excipients and information for the package leaflet Name Updated on Route of Threshold Information for the Package Leaflet Comments Administration Aprotinin Topical Zero May cause hypersensitivity or severe allergic The topical route in this case refers to sites that may reactions. have access to the circulation (e.g. wounds, body cavities etc.)