Transcription of ASSESSMENT REPORT FOR Janumet
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ASSESSMENT REPORT FOR Janumet
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 84 16 E-mail: European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged :EMEA/255349/2008 ASSESSMENT REPORT FOR Janumet International Nonproprietary Name: sitagliptin / metformin hydrochloride Procedure No. EMEA/H/C/000861 ASSESSMENT REPORT as adopted by the CHMP with all information of a commercially confidential nature deleted. 2/43 TABLE OF CONTENTS 1. BACKGROUND INFORMATION ON THE PROCEDURE 3 Submission of the dossier .. 3 Steps taken for the ASSESSMENT of the 4 2. SCIENTIFIC DISCUSSION 5 5 Quality aspects .. 7 Non-clinical aspects .. 9 Clinical aspects .. 15 40 Overall conclusions, risk/benefit ASSESSMENT and recommendation.
6/43 an adjunct to diet and exercise in patients inadequately controlled with any two of the three agents: metformin, sitagliptin, or a sulphonylurea.
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