Transcription of Excipients and information for the package leaflet EN
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Excipients and information for the package leaflet EN
9 October 2017. EMA/CHMP/302620/2017. 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 2017. Adopted by EMA Committee for Medicinal Products for Human Use (CHMP) 20 July 2017. Endorsed by European Commission's Notice to Applicants Group 4 October 2017. Date of publication 9 October 2017. This document updates and 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 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 reactions.
Name Updated on Route of Administration Threshold Information for the Package Leaflet Comments Benzyl alcohol 09/10/2017. Oral, parenteral Zero Ask your doctor or pharmacist for advice if you are
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