Transcription of Assessment report - European Medicines Agency
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Assessment report - European Medicines Agency
EMA/662938/2011. Committee for Medicinal Products for Human Use (CHMP). Assessment report Buccolam midazolam Procedure No.: EMEA/H/C/002267. Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455. E-mail Website An Agency of the European Union European Medicines Agency , 2011. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure.
The application submitted is composed of administrative information, complete quality data, a pharmacokinetic study and appropriate non-clinical and clinical data.
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