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We have today made available the Public Information Report for Sativex, an unlicensed, cannabis-based medicine used for the relief of spasticity in people with multiple sclerosis.
An application for a marketing authorisation for Sativex Oromucosal Spray was submitted by GW Pharma Ltd in August 2006 via the European Decentralised procedure involving a number of member states with the UK acting as the Reference Member State (RMS). Before the procedure was formally concluded, GW Pharma Ltd decided to withdraw the application from final determination. Although the marketing authorisation application was withdrawn before the end of the procedure, Sativex has been supplied on a named patient basis in the UK to approximately 1200 patients to date.
The MHRA therefore considers that it is in the interest of public health to provide potential prescribers with information on the MHRA’s assessment of quality, safety and efficacy of Sativex in the relief of spasticity in people with multiple sclerosis in the form of a public information report based on the information submitted by the company in support of its application up to the date of withdrawal.
There has also been public interest in the licensing of Sativex and we wish to inform the public about its current position.
Sativex Oromucosal Spray (Tetranabinex and Nabidiolex, as extract of Cannabis sativa L.) - UK/H/961/01/DC 
