EU/3/19/2200 : Orphan designation for the treatment of nontuberculous mycobacterial lung disease
Table of contents
On 21 August 2019, orphan designation EU/3/19/2200 was granted by the European Commission to Dr Sebastian Canisius, Germany, for clofazimine for the treatment of nontuberculous mycobacterial lung disease.
Treatment of nontuberculous mycobacterial lung disease
|Orphan designation status||
|EU designation number||
|Date of designation||
ACliRA Consulting ApS
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
|March 2023||The sponsorship was transferred from ACliRA Consulting GmbH, Germany, to ACliRA Consulting ApS, Denmark.|
|February 2023||The sponsor's address was updated.|
|January 2021||The sponsorship was transferred to Aclira Consulting GmbH, Germany.|
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: