EU/3/02/100: Orphan designation for the treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency

Recombinant human alpha-1 antitrypsin

Table of contents

Overview

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in May 2012 on request of the sponsor.

On 30 April 2002, orphan designation (EU/3/02/100) was granted by the European Commission to Baxter AG, Austria, for recombinant human alpha-1 antitrypsin for the treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency.

The sponsorship was transferred to MDS Pharma Services France SAS, France, in October 2006 and subsequently to Fulcrum Pharma (Europe) Ltd., United Kingdom, in July 2008.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Recombinant human alpha-1 antitrypsin
Intended use
Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Orphan designation status
Withdrawn
EU designation number
EU/3/02/100
Date of designation
30/04/2002
Sponsor
Fulcrum Pharma (Europe) Ltd
Hemel One
Boundary Way
Hemel Hempstead
Hertfordshire, HP2
Tel. +44 (0)1442 283 600
Fax +44 (0)1442 283 613
E-mail: jenny.vestal@fulcrumpharma.com

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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