EU/3/13/1103

About

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
Disease / condition
Treatment of chronic thromboembolic pulmonary hypertension
Date of first decision
08/02/2013
Outcome
Positive
EU designation number
EU/3/13/1103

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 iconorphan medicine assessment report .

Sponsor's contact details

SciPharm S.a.r.l. 
26-28 Rue Edward Steichen
L-2540 Luxembourg
Luxembourg
E-mail: office@scipharm.eu

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.

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