Transcription of Assessment report - Europa
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Assessment report - Europa
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 21 May 2015 EMA/444458/2015 Rev 1 Committee for Medicinal Products for Human Use (CHMP) Assessment report Keytruda International non-proprietary name: pembrolizumab Procedure No. EMEA/H/C/003820/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Page 2/160 Table of contents 1. Background information on the procedure .. 7 Submission of the dossier .. 7 Manufacturers .. 8 Steps taken for the Assessment of the product .. 8 2. Scientific discussion .. 9 9 Quality aspects .. 11 Introduction .. 11 Active Substance .. 11 Finished Medicinal Product .. 13 Discussion on chemical, pharmaceutical and biological aspects.
ECOG Eastern Cooperative Oncology Group . ELISA Enzyme-Linked Immunosorbent assay . EORTC- QLQ European Organisation for Research and Treatment of Care core Quality of Life . Page 4/160 questionnaire . ERA Environmental Risk Assessment . eGFR Estimated glomerular filtration rate . FAS Full Analysis Set ...
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