GW Pharma files new regulatory application to expand Sativex® approvals in Europe
GW Pharmaceuticals plc today announced that it has submitted an application under the European Mutual Recognition Procedure (MRP) to seek to expand the marketing authorization for Sativex® to a number of additional European member states.
The new MRP follows successful completion of a previous MRP earlier this year in which recommendation for approval of Sativex® was obtained from regulatory authorities in Germany, Italy, Denmark, Sweden, Austria and the Czech Republic. Prior to this, Sativex® received approval in 2010 in the UK and Spain.
The complete list of countries to which the MRP application is being made is currently being finalised. The list is expected to include approximately ten new countries and will mean that if this MRP process is successful, approaching twenty European countries will have recommended approval of Sativex.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1814