EU/3/13/1103: Orphan designation for the treatment of chronic thromboembolic pulmonary hypertension
Treprostinil sodium
Table of contents
Overview
On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.
The medicinal product for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension has been authorised in the EU as Trepulmix since 03 April 2020.
Key facts
Active substance |
Treprostinil sodium
|
Intended use |
Treatment of chronic thromboembolic pulmonary hypertension
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/13/1103
|
Date of designation |
08/02/2013
|
Sponsor |
SciPharm S.a.r.l. |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Trepulmix at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the
orphan medicine assessment report
.
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: