The Medicines Safety Agency has authorized the marketing of Sativex, a medicinal product derived from cannabis. It will be prescribed in 2015 for patients with multiple sclerosis.
Sativex, a drug derived from cannabis, received its marketing authorization (AMM) on January 8. The Ministry of Health announced it on January 9, in a brief press release.
The marketing authorization opens up the possibility of marketing this oral spray. It is the first cannabis-based drug to be authorized in France. It will be intended for patients suffering from multiple sclerosis, “to relieve severe contractures (spasticity), resistant to other treatments.” “Only neurologists and hospital rehabilitators will be able to prescribe Sativex,” said the ministry.
Sativex, produced by GW Pharmaceuticals, is already authorized in the United States, but also in the United Kingdom and Germany. In France, the Almirall laboratory should be in charge of marketing the drug.
On June 5, Marisol Touraine, Minister of Social Affairs and Health, opened by decree the possibility of marketing a cannabis-based drug. GW Pharmaceuticals was the first to seize the opportunity. On October 21, the European Medicines Agency (EMA) issues a favorable recommendation for Sativex. This decision makes marketing authorization possible. The ANSM spokesperson then hoped that the authorization would be effective “in the first quarter of 2014” in order to market the oral spray in 2015. For the moment, the schedule is respected.
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