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. 1 includes an update of July 201720 July 20174 October 2017 NameUpdated on Route of AdministrationThresholdInformation for the package LeafletCommentsAprotininTopicalZeroMay cause hypersensitivity or severe allergic topical route in this case refers to sites that may have access to the circulation ( wounds, body cavities etc.)
Oral, parenteral Zero <Benzoic acid/Benzoate salt> may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).
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