EU/3/10/786: Orphan designation for the treatment of tuberculosis

Heat-killed Mycobacterium vaccae (whole cell)


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
EU designation number
Date of designation

Regintel Limited
Carlingford A91 X097
Co. Louth

Review of designation

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

Documents related to this orphan designation evaluation

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:

How useful was this page?

Add your rating