Sativex® mutual recognition procedure closes

A cannabis derived drug which has been approved in some countries to treat muscle spasticity.

Sativex® mutual recognition procedure closes

Postby MSUK » Tue May 08, 2012 4:57 am

Sativex® mutual recognition procedure closes with recommendation for approval in ten european countries

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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
MS-UK - http://www.ms-uk.org/
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