Transcription of Excipients and information for the package leaflet EN v1
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Excipients and information for the package leaflet EN v1
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 Adopted by EMA Committee for Medicinal Products for Human Use (CHMP) Endorsed by European Commission's Notice to Applicants Group 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.
All Zero This medicine contains x mg benzyl alcohol in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>. Benzyl alcohol may cause allergic reactions. Benzyl alcohol 09/10/2017. Oral, parenteral Zero Benzyl alcohol has been linked with the risk of
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