On 18 November 2016, orphan designation (EU/3/16/1783) was granted by the European Commission to EMAS Pharma Limited, United Kingdom, for N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide (also called CM4620) for the treatment of acute pancreatitis.
The sponsorship was transferred:
• to Cogas Pharma Limited, Ireland in April 2017;
• to Reglntel Ltd, Ireland in July 2018 and
• to Turnkey Pharmaconsulting Ireland Limited, Ireland in July 2020.
Treatment of acute pancreatitis
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Turnkey PharmaConsulting Ireland Limited
Documents related to this orphan designation evaluation
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.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: