Transcription of Assessment report - European Medicines Agency
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Assessment report - European Medicines Agency
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 , 2017. Reproduction is authorised provided the source is acknowledged. 22 June 2017 EMA/CHMP/559383/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Imraldi International non-proprietary name: adalimumab Procedure No. EMEA/H/C/004279/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/559383/2017 Page 2/111 Table of contents 1. Background information on the procedure .. 8 Submission of the dossier .. 8 Steps taken for the Assessment of the product .. 10 2. Scientific discussion .. 11 Problem statement .. 11 Disease or condition .. 11 Biologic features .. 13 Quality aspects .. 14 Introduction .. 14 Active Substance.
Assessment report EMA/CHMP/559383/2017 Page 5/111 . ESR Erythrocyte sedimentation rate . ET Early termination . EU European Union
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