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67 results
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Human medicine European public assessment report (EPAR): Orphacol
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,,
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, Revision: 11, Authorised, Last updated: 23/06/2021
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,,
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, Revision: 5, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,,
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, Revision: 13, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,,
, Revision: 24, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Kolbam
cholic acid, Metabolism, Inborn Errors
Date of authorisation: 20/11/2015,, Revision: 14, Withdrawn, Last updated: 15/07/2020
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Human medicine European public assessment report (EPAR): Vedrop
tocofersolan, Cholestasis; Vitamin E Deficiency
Date of authorisation: 23/07/2009,,
, Revision: 13, Authorised, Last updated: 22/08/2019
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Human medicine European public assessment report (EPAR): ATryn
Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006,,
, Revision: 16, Withdrawn, Last updated: 02/07/2019
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Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,,
, Revision: 12, Authorised, Last updated: 01/08/2018
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Human medicine European public assessment report (EPAR): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
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): Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) , Influenza, Human; Immunization; Disease Outbreaks
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
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human; Immunization; Disease Outbreaks
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)
Rilonacept, Cryopyrin-Associated Periodic Syndromes
Date of authorisation: 23/10/2009,, Revision: 5, Withdrawn, Last updated: 30/10/2012
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Veterinary medicine European public assessment report (EPAR): Poulvac Flufend H5N3 RG
recombinant inactivated avian influenza virus, Chicken; Ducks
Date of authorisation: 01/09/2006,,
, Revision: 8, Withdrawn, Last updated: 07/05/2012
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Human medicine European public assessment report (EPAR): Xigris
drotrecogin alfa (activated), Sepsis; Multiple Organ Failure
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
Celecoxib, Adenomatous Polyposis Coli
Date of authorisation: 17/10/2003,, Revision: 13, Withdrawn, Last updated: 06/04/2011
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N6
inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), Chicken
Date of authorisation: 31/01/2008,,
, Revision: 1, Withdrawn, Last updated: 26/07/2010
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H7N1
inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), Chicken; Ducks
Date of authorisation: 14/05/2007,,
, Revision: 2, Withdrawn, Last updated: 26/07/2010
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Human medicine European public assessment report (EPAR): Evkeeza
Evinacumab, Hypercholesterolemia
Date of authorisation: 17/06/2021,,
, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Zokinvy (new)
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,,
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, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Upstaza
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,,
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, Authorised, Last updated: 20/05/2022
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Orphan designation: Carboxypeptidase G2 (glucarpidase) for: Adjunctive treatment in patients at risk of methotrexate toxicity
Date of designation: 03/02/2003, Positive, Last updated: 20/01/2022 -
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Orphan designation: Chimeric monoclonal antibody against GD2 for: Treatment of neuroblastoma
Date of designation: 08/11/2012, Positive, Last updated: 26/08/2021 -
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Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid for: Treatment of progressive familial intrahepatic cholestasis
Date of designation: 17/07/2012, Positive, Last updated: 28/07/2021 -
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Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein for: Treatment of blastic plasmacytoid dendritic cell neoplasm
Date of designation: 11/11/2015, Positive, Last updated: 25/01/2021 -
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Orphan designation: Obiltoxaximab for: Treatment of anthrax
Date of designation: 24/08/2018, Positive, Last updated: 27/11/2020