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 .. 4. Submission of the 4. Manufacturers .. 5. Steps taken for the Assessment of the product .. 5. 2. Scientific discussion .. 6. Introduction .. 6. Quality aspects .. 8. Introduction .. 8. Active 8. Finished Medicinal Product .. 9. Discussion on chemical, pharmaceutical and biological 13.
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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