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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

[gly2] Recombinant human glucagon-like peptide

EU orphan designation number: EU/3/01/077   
Active ingredient: [gly2] Recombinant human glucagon-like peptide
Indication: Treatment of Short Bowel Syndrome
Sponsor: Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Revestive on 30/08/2012 with the number EU/1/12/787

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
13/12/2001 Orphan designation EMEA/OD/045/01 (2001)4108 of 11/12/2001
06/11/2002 Transfer of orphan designation EMEA/OD/045/01/T/01 (2002)4295 of 04/11/2002
14/03/2005 Change of name and/or address of sponsor
24/04/2008 Transfer of orphan designation EMEA/OD/045/01/T/02 (2008)1687 of 22/04/2008
30/09/2013 Change of name and/or address of sponsor
23/10/2013 Transfer of orphan designation EMEA/OD/045/01/T/03 (2013)7102 of 21/10/2013
31/03/2016 Change of name and/or address of sponsor
15/04/2016 Transfer of orphan designation EMA/OD/045/01/T/04 (2016)2265 of 13/04/2016
06/11/2017 Change of name and/or address of sponsor