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Medicine
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Human medicine European public assessment report (EPAR): Ruxience
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell, Arthritis, Rheumatoid, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 01/04/2020,,
, Revision: 2, Authorised, Last updated: 17/09/2020
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,,
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, Revision: 6, Authorised, Last updated: 31/08/2020
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 11, Authorised, Last updated: 24/08/2020
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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: 9, Authorised, Last updated: 11/08/2020
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Human medicine European public assessment report (EPAR): Inhixa
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,,
, Revision: 16, Authorised, Last updated: 23/07/2020
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Human medicine European public assessment report (EPAR): Trazimera
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018,,
, Revision: 6, Authorised, Last updated: 09/07/2020
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,,
, Revision: 20, Authorised, Last updated: 24/06/2020
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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: 4, Authorised, Last updated: 12/06/2020
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Human medicine European public assessment report (EPAR): Nivestim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 07/06/2010,, Revision: 22, Authorised, Last updated: 10/06/2020
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Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,,
, Revision: 5, Authorised, Last updated: 25/05/2020
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Human medicine European public assessment report (EPAR): Increlex
Mecasermin, Laron Syndrome
Date of authorisation: 02/08/2007,,
, Revision: 21, Authorised, Last updated: 20/04/2020
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Human medicine European public assessment report (EPAR): Grasustek
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,,
, Revision: 1, Authorised, Last updated: 31/03/2020
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Human medicine European public assessment report (EPAR): Lojuxta
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,,
, Revision: 12, Authorised, Last updated: 25/03/2020
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi
insulin lispro, Diabetes Mellitus
Date of authorisation: 18/07/2017,,
, Revision: 5, Authorised, Last updated: 24/03/2020
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Human medicine European public assessment report (EPAR): Ogivri
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 12/12/2018,,
, Revision: 3, Authorised, Last updated: 18/03/2020
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Human medicine European public assessment report (EPAR): Hulio
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 16/09/2018,,
, Revision: 4, Authorised, Last updated: 17/03/2020
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Human medicine European public assessment report (EPAR): Amgevita
adalimumab, Arthritis, Psoriatic, Colitis, Ulcerative, Arthritis, Juvenile Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,,
, Revision: 8, Authorised, Last updated: 12/03/2020
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,,
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, Revision: 8, Authorised, Last updated: 28/01/2020
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Human medicine European public assessment report (EPAR): Ziextenzo
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,,
, Revision: 2, Authorised, Last updated: 13/01/2020
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Human medicine European public assessment report (EPAR): Riximyo
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 15/06/2017,,
, Revision: 4, Authorised, Last updated: 13/01/2020
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Human medicine European public assessment report (EPAR): Udenyca
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,,
, Revision: 3, Authorised, Last updated: 29/11/2019
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018,,
, Revision: 6, Authorised, Last updated: 29/11/2019
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Human medicine European public assessment report (EPAR): Rixathon
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 15/06/2017,,
, Revision: 3, Authorised, Last updated: 28/11/2019
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Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 10/10/2009,, Revision: 10, Authorised, Last updated: 06/11/2019
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Human medicine European public assessment report (EPAR): Binocrit
epoetin alfa, Anemia, Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 20, Authorised, Last updated: 31/10/2019