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39 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Opinions on maximum residue limits Remove Opinions on maximum residue limits filter
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Human medicine European public assessment report (EPAR): Gamifant (updated)
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,
, Refused, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Udenyca
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,
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, Revision: 3, Withdrawn, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
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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, Revision: 14, Withdrawn, Last updated: 15/07/2020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): Kromeya
adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease
Date of authorisation: 02/04/2019,, , Revision: 4, Withdrawn, Last updated: 25/03/2020
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Human medicine European public assessment report (EPAR): Thorinane
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 14/09/2016,, , Revision: 2, Withdrawn, Last updated: 24/10/2019
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Human medicine European public assessment report (EPAR): Rituzena (previously Tuxella)
rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 7, Withdrawn, Last updated: 08/07/2019
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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): Cyltezo
adalimumab, Hidradenitis Suppurativa, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing
Date of authorisation: 10/11/2017,, , Revision: 2, Withdrawn, Last updated: 06/03/2019
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Human medicine European public assessment report (EPAR): Solymbic
adalimumab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Crohn Disease, Colitis, Ulcerative, Hidradenitis Suppurativa, Psoriasis, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,, , Revision: 2, Withdrawn, Last updated: 05/03/2019
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Human medicine European public assessment report (EPAR): Lusduna
insulin glargine, Diabetes Mellitus
Date of authorisation: 03/01/2017,, Revision: 2, Withdrawn, Last updated: 22/01/2019
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Human medicine European public assessment report (EPAR): Alsitek
Masitinib mesilate, Amyotrophic Lateral Sclerosis
Date of refusal: 26/07/2018,, Refused, Last updated: 31/07/2018
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Human medicine European public assessment report (EPAR): Masipro
Masitinib mesilate, Mastocytosis
Date of refusal: 18/12/2017,, Refused, Last updated: 04/04/2018
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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): Biograstim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,, Revision: 8, Withdrawn, Last updated: 19/01/2017
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Human medicine European public assessment report (EPAR): Dropcys
mercaptamine, Corneal Diseases, Cystinosis
Date of refusal: 24/06/2016,, Refused, Last updated: 25/07/2016
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Human medicine European public assessment report (EPAR): Heparesc
Human heterologous liver cells, Urea Cycle Disorders, Inborn
Date of refusal: 21/12/2015,, Refused, Last updated: 04/04/2016
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Human medicine European public assessment report (EPAR): Solumarv
insulin human, Diabetes Mellitus
Date of refusal: 11/02/2016,, Refused, Last updated: 16/02/2016
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Human medicine European public assessment report (EPAR): Lympreva
dasiprotimut-t, Lymphoma, Non-Hodgkin
Date of refusal: 03/07/2015,, Refused, Last updated: 17/07/2015
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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): Masiviera
masitinib, Pancreatic Neoplasms, Refused, Last updated: 06/01/2015
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Human medicine European public assessment report (EPAR): Masican
masitinib, Gastrointestinal Stromal Tumors
Date of refusal: 04/07/2014,, Refused, Last updated: 22/11/2013
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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): Istodax
romidepsin, Lymphoma, Non-Hodgkin
Date of refusal: 12/02/2013,, Refused, Last updated: 14/03/2013
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Human medicine European public assessment report (EPAR): Elelyso
Taliglucerase alfa, Gaucher Disease
Date of refusal: 25/10/2012,, Refused, Last updated: 23/11/2012