EU/3/16/1736

Table of contents

About

On 14 October 2016, orphan designation (EU/3/16/1736) was granted by the European Commission to TMC Pharma Services Ltd, United Kingdom, for (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid (also known as JBT-101) for the treatment of cystic fibrosis.

The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland, in July 2019.

This medicine is now known as lenabasum.

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

Key facts

Active substance
(6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid-
Disease / condition
Treatment of cystic fibrosis
Date of first decision
14/10/2016
Outcome
Positive
EU designation number
EU/3/16/1736

Sponsor's contact details

Pharma Gateway AB
Johanneslundsvägen 2
Hammarby
194 61 Upplands Väsby
Stockholms Lan
Sweden
Tel. +46 8 590 778 00
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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