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Sativex® receives regulatory approval in Israel

Neopharm Group and GW Pharmaceuticals plc announced that Sativex® (Delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) oromucosal spray) has received regulatory approval from the Israeli Ministry of Health for the treatment of spasticity and neuropathic pain due to multiple sclerosis (MS).

Sativex® will be launched in the next few months.  Clalit health services, Israel’s largest health fund, will fund the medicine through its supplementary insurance coverage.  At the same time, Sativex® has been filed for national reimbursement for 2013. A decision on this is expected by the end of 2012.

sativex spray


In Israel, Sativex will be marketed by the Neopharm Group, Israel’s second largest pharmaceuticals and health products marketer.

Sativex® is currently available as a prescription medicine in the UK, Spain, Germany, Denmark, Canada and New Zealand.  It is also approved in Italy, Sweden, Austria and the Czech Republic and market launches are expected in those countries later this year.   Further applications are under review by regulatory authorities in Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.

Sativex® has been developed by GW Pharmaceuticals and is marketed in Europe (except the UK) by Almirall. The medicine is also in Phase III clinical development as a treatment for cancer pain.

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