13 December 2012 EMA/91055/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Adasuve International non-proprietary name: loxapine Procedure No. EMEA/H/C/002400 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
[email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. Contents 1. Background information on the procedure .............................................. 8 1.1. Submission of the dossier .................................................................................... 8 Information on Paediatric requirements ....................................................................... 8 Information relating to orphan market exclusivity .......................................................... 8 Scientific Advice ....................................................................................................... 8 Licensing status ....................................................................................................... 8 1.2. Steps taken for the assessment of the product ....................................................... 9 2. Scientific discussion .............................................................................. 10 2.1. Introduction ...................................................................................................