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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Recombinant human alpha-1 antitrypsin

EU orphan designation number: EU/3/02/100
Active ingredient: Recombinant human alpha-1 antitrypsin
Indication: Treatment of emphysema secondary to congenital alpha-1-antitrypsin deficiency
Sponsor: Aptiv Solutions (UK) Ltd
3 Glory Park Avenue, Wooburn Green, Bucks HP10 0DF, United Kingdom

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
03/05/2002 Orphan designation EMEA/OD/048/01 (2002)1829 of 30/04/2002
19/10/2006 Transfer of orphan designation EMEA/OD/048/01/T/01 (2006)5012 of 17/10/2006
29/07/2008 Transfer of orphan designation EMEA/OD/048/01/T/02 (2008)4098 of 25/07/2008
09/11/2010 Change of name and/or address of sponsor EMA/581201/2010
14/03/2011 Change of name and/or address of sponsor EMEA/OD/048/01
21/05/2012 Removal of orphan designation from Community Register