利拉鲁肽欧洲申报资料WC500050016.pdf

European Medicines Agency Evaluation of Medicines for Human Use Doc.Ref.: EMEA/379172/2009 ASSESSMENT REPORT FOR Victoza International Nonproprietary Name: liraglutide Procedure No. EMEA/H/C/001026 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: mail@emea.europa.eu http://www.emea.europa.eu © European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged. TABLE OF CONTENTS 1. BACKGROUND INFORMATION ON THE PROCEDURE 3 1.1 Submission of the dossier 3 1.2 Steps taken for the assessment of the product 3 2 SCIENTIFIC DISCUSSION 4 2.1 Introduction 4 2.2 Quality aspects 4 2.3 Non-clinical aspects 8 2.4 Clinical aspects 15 2.5 Pharmacovigilance 42 2.6 Overall conclusions, risk/benefit assessment and recommendation 44 Page 2 of 49 1. BACKGROUND INFORMATION ON THE PROCEDURE 1.1 Submission of the dossier The applicant Novo Nordisk A/S submitted on 23 May 2008 an application for Marketing Authorisation to the European Medicines Agency (EMEA) for Victoza, through the centralised procedure falling within the Article 3(1) and point 3 of Annex of Regulation (EC) No