EU/3/18/2070

About

On 26 October 2018, orphan designation (EU/3/18/2070) was granted by the European Commission to Accelsiors CRO and Consultancy Services Ltd, Hungary, for (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid (also known as lenabasum) for the treatment of dermatomyositis.

The sponsorship was transferred to Pharma Gateway AB, Sweden, in July 2020.

Key facts

Active substance
(6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid
Disease / condition
Treatment of dermatomyositis
Outcome
Positive
EU designation number
EU/3/18/2070

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Pharma Gateway AB
Johanneslundsvägen 2
194 61 Upplands Väsby
Stockholms Lan
Sweden
E-mail: info@pharmagateway.eu

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

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