Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in December 2008 on request of the sponsor.
On, 30 May 2001 orphan designation (EU/3/01/041) was granted by the European Commission to Bayer AG, Germany, recombinant human alpha-1 antitrypsin for the treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency.
The sponsorship was transferred to Talecris Biotherapeutics GmbH, Germany in March 2007.
Recombinant human alpha-1 antitrypsin
Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
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Documents related to this orphan designation evaluation
EU/3/01/041: Public summary of positive opinion for orphan designation of recombinant human alpha-1 antitrypsin for the treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency (PDF/119.1 KB)
First published: 15/05/2009
Last updated: 15/05/2009
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
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: