Transcription of CHMP ASSESSMENT REPORT FOR Ellaone
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CHMP ASSESSMENT REPORT FOR Ellaone
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) 75 23 70 51 E-mail: : EMEA/261787/2009 CHMP ASSESSMENT REPORT FOR Ellaone International Nonproprietary Name: ulipristal acetate Procedure No. EMEA/H/C/001027 ASSESSMENT REPORT as adopted by the CHMP with all information of a commercially confidential nature deleted. 2/49 TABLE OF CONTENTS 1. BACKGROUND INFORMATION ON THE PROCEDURE .. 3 Submission of the dossier .. 3 Steps taken for the ASSESSMENT of the 3 2. SCIENTIFIC 4 4 Quality aspects .. 5 Non-clinical aspects .. 8 Clinical aspects .. 18 40 Overall conclusions, risk/benefit ASSESSMENT and recommendation .. 46 3/49 1. BACKGROUND INFORMATION ON THE PROCEDURE Submission of the dossier The applicant Laboratoire HRA Pharma submitted on 30 May 2008 an application for Marketing Authorisation to the European Medicines Agency (EMEA) for Ellaone , through the centralised procedure under Article 3 (2) (a) of Regulation (EC) No 726/2004.
5/49 The National Institute of Child Health and Human Development (NICHD) initiated the clinical development phase of ulipristal acetate for use as an emergency contraception.
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