EU/3/10/786: Orphan designation for the treatment of tuberculosis
Heat-killed Mycobacterium vaccae (whole cell)
Table of contents
Overview
On 20 September 2010, orphan designation (EU/3/10/786) was granted by the European Commission to Immodulon Therapeutics Ltd, United Kingdom, for heat-killed Mycobacterium vaccae (whole cell) for the treatment of tuberculosis.
The sponsorship was transferred to Immodulon Therapeutics B.V., in July 2019.
The sponsorship was transferred to Regintel Limited, Ireland in March 2022.
Key facts
Active substance |
Heat-killed Mycobacterium vaccae (whole cell)
|
Intended use |
Treatment of tuberculosis
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/10/786
|
Date of designation |
20/09/2010
|
Sponsor |
Regintel Limited |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
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.
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: