Transcription of CHMP ASSESSMENT REPORT Adenuric
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CHMP ASSESSMENT REPORT Adenuric
European Medicines Agency Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged. Doc Ref : EMEA/258531/2008 CHMP ASSESSMENT REPORT FOR Adenuric International Nonproprietary Name: febuxostat Procedure No. EMEA/H/C/777 ASSESSMENT REPORT as adopted by the CHMP with all information of a commercially confidential nature deleted. TABLE OF CONTENS 1. BACKGROUND INFORMATION ON THE 3 Submission of the 3 Steps taken for the ASSESSMENT of the 3 2. SCIENTIFIC 4 4 Quality 5 Non-clinical 8 Clinical 18 47 Overall conclusions, risk/benefit ASSESSMENT and 49 EMEA 2008 2/51 1. BACKGROUND INFORMATION ON THE PROCEDURE Submission of the dossier The applicant Ipsen Manufacturing Ireland Ltd.
The application was received by the EMEA on 23 August 2006. • The procedure started on 27 September 2006. • The Rapporteur's first Assessment Report was circulated to all CHMP members on 8 December
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