EU/3/13/1103: Orphan designation for the treatment of chronic thromboembolic pulmonary hypertension

Treprostinil sodium

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. 
26-28 Rue Edward Steichen
L-2540 Luxembourg
Luxembourg
E-mail: office@scipharm.eu

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 PDF icon orphan medicine assessment report .

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:

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