Sativex® mutual recognition procedure closes
Posted: Tue May 08, 2012 3:57 am
Sativex® mutual recognition procedure closes with recommendation for approval in ten european countries
GW Pharmaceuticals plc and Almirall S.A. today announce the successful completion of the European Mutual Recognition Procedure (MRP) for Sativex® oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS).
Following previous positive regulatory submissions in the UK, Spain, Germany, Italy, Denmark Sweden, Austria, Czech Republic, a MRP application was made to expand the availability of Sativex® to ten additional European countries. The MRP has now closed successfully with regulatory authorities in all ten countries confirming that Sativex® meets their requirements for approval. The countries involved in the MRP and in which Sativex® is expected to be approved are: Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.
"For Almirall, the successful completion of this second MRP regulatory process for Sativex® represents very good news and reinforces our commitment to expand this innovative medicine to MS patients across Europe. Sativex® is the first treatment specifically indicated for the treatment of spasticity, and related symptoms, in MS patients" said Bertil Lindmark, Chief Scientific Officer at Almirall....Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1814
GW Pharmaceuticals plc and Almirall S.A. today announce the successful completion of the European Mutual Recognition Procedure (MRP) for Sativex® oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS).
Following previous positive regulatory submissions in the UK, Spain, Germany, Italy, Denmark Sweden, Austria, Czech Republic, a MRP application was made to expand the availability of Sativex® to ten additional European countries. The MRP has now closed successfully with regulatory authorities in all ten countries confirming that Sativex® meets their requirements for approval. The countries involved in the MRP and in which Sativex® is expected to be approved are: Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.
"For Almirall, the successful completion of this second MRP regulatory process for Sativex® represents very good news and reinforces our commitment to expand this innovative medicine to MS patients across Europe. Sativex® is the first treatment specifically indicated for the treatment of spasticity, and related symptoms, in MS patients" said Bertil Lindmark, Chief Scientific Officer at Almirall....Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1814