Prescriber Information
Sativex® is GW's lead cannabinoid pharmaceutical product, administered as an oral spray which is absorbed by the patient’s mouth.
Sativex is approved and marketed in the UK, Spain and Canada to treat spasticity due to Multiple Sclerosis. If you are a prescriber and would like to obtain further information on Sativex:
- in the UK, please click here.
- in Spain, please click here.
- in Germany, please click here.
- in Canada, please click here
- in New Zealand, please click here.
In additional European countries, Sativex has successfully completed the European Mutual Recognition Procedure (MRP) with the regulatory authorities in six member states (Germany, Italy, Denmark, Sweden, Austria and the Czech Republic) confirming that Sativex meets their requirements for approval. The next step in the regulatory process involves separate national phases in each country to finalise local wording on product packaging and related documents and also to agree any other country-specific requirements. Following completion of the national step, we expect each country to then issue a national marketing authorisation. We anticipate launch before the end of 2011 in Germany, Denmark and Sweden with the remaining countries expected in 2012.
In Canada, as well as being approved for the treatment of spasticity due to multiple sclerosis, Sativex is also approved under the Notice of Compliance with Conditions (NOC/c) policy for symptomatic relief of neuropathic pain in Multiple Sclerosis and as adjunctive analgesic treatment in patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.
The current position regarding the availability of Sativex varies between different countries according to whether Sativex has been approved by the medical regulatory authority in the country and also on the local regulations regarding the prescribing of controlled drugs and unlicensed medicines.
If you would like to obtain further information on obtaining Sativex please click here.