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Medicalcannabis

Evolving legislature

Sep. 04, 2023 by SOMAÍ Pharmaceuticals

Evolving legislature

There is little consistency across Europe relating to when cannabis-based products may be used for medicinal purposes, and for which conditions. Clinical trials are showing good results in several therapeutic areas, but there are currently only four pharmaceutical cannabis formulations approved in Europe, of which only Epidiolex® (cannabidiol) has received Europe-wide approval for the treatment of Dravet syndrome and Lennox-Gastaut syndrome – rare and severe forms of epilepsy.

Pharmaceutical cannabis formulations currently approved in Europe

It is a complex market which is growing fast, so there is likely to be rapid parallel evolution in the regulatory environment for medicinal cannabinoid products.

Pharmaceutical cannabis formulations currently approved in Europe

Brand name Cannabinoid component Indication European counties approved
Epidiolex® Cannabidiol Lennox-Gastaut syndrome and Dravet syndrome All 27 countries of the EU, alongside Norway, Iceland and Liechtenstein
Sativex® Nabiximols (plant-derived Δ9-THC and CBD at a ratio of 1:1) Spasticity associated with multiple sclerosis 22 countries, including France, Germany, Italy, Poland, Spain, and the UK
Cesamet® Nabilone (Δ9-THC analogue) Nausea and vomiting associated with chemotherapy 11 countries, including Germany, Ireland, Norway, Poland, Spain, and the UK
Marinol® Dronabinol Nausea and appetite loss due to chemotherapy, HIV or AIDS 13 countries, including France, Germany, Poland, Spain, Sweden, and Switzerland