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110 results
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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): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 3, Authorised, Last updated: 28/05/2020
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Human medicine European public assessment report (EPAR): Waylivra
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,, , 
, Revision: 2, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Natpar
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 8, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 13, Authorised, Last updated: 11/05/2020
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, , , , Revision: 2, Authorised, Last updated: 06/05/2020
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 6, Authorised, Last updated: 05/05/2020
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Human medicine European public assessment report (EPAR): Rubraca
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 4, Authorised, Last updated: 29/04/2020
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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): 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): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, , Revision: 23, Authorised, Last updated: 23/03/2020
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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 5, Authorised, Last updated: 06/03/2020
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Human medicine European public assessment report (EPAR): Sirturo
bedaquiline fumarate, Tuberculosis, Multidrug-Resistant
Date of authorisation: 05/03/2014,, , , Revision: 17, Authorised, Last updated: 06/03/2020
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Human medicine European public assessment report (EPAR): Pixuvri
pixantrone dimaleate, Lymphoma, Non-Hodgkin
Date of authorisation: 10/05/2012,, , Revision: 22, Authorised, Last updated: 02/03/2020
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Human medicine European public assessment report (EPAR): Vyndaqel
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , , Revision: 16, Authorised, Last updated: 25/02/2020
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Human medicine European public assessment report (EPAR): Zalmoxis
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation, Graft vs Host Disease
Date of authorisation: 18/08/2016,, Revision: 1, Withdrawn, Last updated: 14/02/2020
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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,, , , Revision: 8, Authorised, Last updated: 28/01/2020
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, , Revision: 17, Authorised, Last updated: 24/01/2020
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Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , , Revision: 6, Authorised, Last updated: 14/01/2020
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Human medicine European public assessment report (EPAR): Bosulif
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 27/03/2013,, , Revision: 19, Authorised, Last updated: 09/12/2019
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Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 9, Authorised, Last updated: 04/12/2019
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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): Lartruvo
Olaratumab, Sarcoma
Date of authorisation: 09/11/2016,
, , , , Revision: 3, Withdrawn, Last updated: 02/09/2019
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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