EU/3/14/1316: Orphan designation for the treatment of haemophilia A

Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin

Overview

On 22 August 2014, orphan designation (EU/3/14/1316) was granted by the European Commission to Richardson Associates Regulatory Affairs Ltd, United Kingdom, for recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin for the treatment of haemophilia A.

The sponsorship was transferred to Richardson Associates Regulatory Affairs Ltd, Ireland, in December 2018.

The sponsorship was transferred to  Eirgen Pharma Limited, Ireland, in September 2021.

Key facts

Active substance
Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin
Intented use
Treatment of haemophilia A
Orphan designation status
Positive
EU designation number
EU/3/14/1316
Date of designation
22/08/2014
Sponsor

Eirgen Pharma Limited
Westside Business Park
Old Kilmeaden Road
Waterford 
X91 YV67
Ireland
Email: Gillian.Prendergast@eirgen.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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