EU/3/15/1435: Orphan designation for the treatment of systemic sclerosis

Nitroglycerin

Overview

On 12 February 2015, orphan designation (EU/3/15/1435) was granted by the European Commission to Covis Pharma S.à.r.l., Luxemburg, for nitroglycerin for the treatment of systemic sclerosis.

Key facts

Active substance
Nitroglycerin
Intended use
Treatment of systemic sclerosis
Orphan designation status
Positive
EU designation number
EU/3/15/1435
Date of designation
12/02/2015
Sponsor
Covis Pharma S.à.r.l.
Atrium Business Park
33 rue du Puits Romains - Boite 6
L - 8070 Bertrange
Luxembourg
Tel. +35 228 2651
E-mail: regulatory@covispharma.com

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:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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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