EU/3/10/815: Orphan designation for the treatment of postcardiotomy right ventricular failure

sildenafil citrate

Overview

On 26 November 2010, orphan designation (EU/3/10/815) was granted by the European Commission to Pfizer Limited, United Kingdom, for sildenafil citrate for the treatment of postcardiotomy right ventricular failure.

The sponsorship was transferred to Pfizer Europe MA EEIG, Belgium, in October 2018.

Key facts

Active substance
sildenafil citrate
Intended use
treatment of postcardiotomy right ventricular failure
Orphan designation status
Positive
EU designation number
EU/3/10/815
Date of designation
26/11/2010
Sponsor

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Brussels-Capital Region
Belgium
E-mail: orphan_enquiries@pfizer.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:

  • 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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