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58 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Human medicine European public assessment report (EPAR): Increlex
Date of authorisation: 02/08/2007,
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, Revision: 20, Authorised, Last updated: 24/11/2017
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Date of authorisation: 10/04/2017,, , , Revision: 3, Authorised, Last updated: 24/11/2017
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Human medicine European public assessment report (EPAR): Glybera
Date of authorisation: 25/10/2012,, , , Revision: 8, Withdrawn, Last updated: 30/10/2017
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Human medicine European public assessment report (EPAR): Obizur
Date of authorisation: 11/11/2015,, , Revision: 3, Authorised, Last updated: 10/07/2017
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Human medicine European public assessment report (EPAR): Pumarix
Date of authorisation: 04/03/2011,, Revision: 4, Withdrawn, Last updated: 17/03/2015
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Human medicine European public assessment report (EPAR): Daronrix
Date of authorisation: 21/03/2007,, Withdrawn, Last updated: 02/07/2013
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Human medicine European public assessment report (EPAR): Rilonacept Regeneron (previously Arcalyst)
Date of authorisation: 23/10/2009,, Revision: 5, Withdrawn, Last updated: 30/10/2012
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Human medicine European public assessment report (EPAR): Xigris
Date of authorisation: 22/08/2002,, Revision: 13, Withdrawn, Last updated: 21/02/2012
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Human medicine European public assessment report (EPAR): Onsenal
Date of authorisation: 17/10/2003,, Revision: 13, Withdrawn, Last updated: 06/04/2011
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Referral: Factor VIII
?> associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, -
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Orphan designation: for: Treatment of hypophosphatasia
Date of first decision: 04/12/2008, Positive, Last updated: 20/11/2019 -
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Orphan designation: for: Treatment of neuroblastoma
Date of first decision: 08/11/2012, Positive, Last updated: 22/01/2019 -
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Orphan designation: for: Treatment of mucopolysaccharidosis type VII (Sly syndrome)
Date of first decision: 21/03/2012, Positive, -
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Orphan designation: for: Treatment of Barraquer-Simons syndrome
Date of first decision: 17/07/2012, Positive, Last updated: 06/08/2018 -
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Orphan designation: for: Treatment of Berardinelli-Seip syndrome
Date of first decision: 17/07/2012, Positive, Last updated: 06/08/2018 -
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Orphan designation: for: Treatment of Lawrence syndrome
Date of first decision: 17/07/2012, Positive, Last updated: 06/08/2018 -
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Orphan designation: for: Treatment of familial partial lipodystrophy
Date of first decision: 17/07/2012, Positive, Last updated: 06/08/2018 -
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Orphan designation: for: Treatment of Lambert-Eaton myasthenic syndrome
Date of first decision: 19/12/2002, Positive, Last updated: 29/06/2018 -
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Orphan designation: for: Treatment of alpha-mannosidosis
Date of first decision: 26/01/2005, Positive, -
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Orphan designation: for: Treatment of acute lymphoblastic leukaemia
Date of first decision: 16/06/2005, Expired, Last updated: 03/10/2017 -
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Orphan designation: for: Treatment of primary insulin-like growth factor-1 deficiency due to molecular or genetic defects
Date of first decision: 22/05/2006, Expired, Last updated: 03/10/2017 -
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Orphan designation: for: Treatment of inborn errors in primary bile acid synthesis
Date of first decision: 16/12/2014, Positive, Last updated: 29/06/2017 -
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Orphan designation: for: Treatment of mucopolysaccharidosis type II (Hunter's syndrome)
Date of first decision: 11/12/2001, Expired, Last updated: 08/02/2017 -
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Orphan designation: for: Treatment of hepatic veno-occlusive disease
Date of first decision: 29/07/2004, Positive, Last updated: 17/08/2016 -
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Orphan designation: for: Treatment of inborn errors in primary bile acid synthesis
Date of first decision: 18/12/2002, Positive, Last updated: 12/04/2016