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126 results
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,
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, Revision: 20, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, 
, Revision: 16, Authorised, Last updated: 18/05/2020
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, 
, , Revision: 12, Authorised, Last updated: 08/05/2020
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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): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, , , Revision: 4, Authorised, Last updated: 04/05/2020
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Human medicine European public assessment report (EPAR): Coagadex
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,, , , Revision: 5, Authorised, Last updated: 21/04/2020
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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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Veterinary medicine European public assessment report (EPAR): Zulvac 1 Ovis
inactivated bluetongue virus, serotype-1, Sheep
Date of authorisation: 05/08/2011,, Revision: 6, Withdrawn, Last updated: 01/04/2020
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, , Revision: 12, Authorised, Last updated: 31/03/2020
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Veterinary medicine European public assessment report (EPAR): Zulvac 1 Bovis
inactivated bluetongue virus, serotype 1, Cattle
Date of authorisation: 05/08/2011,, Revision: 7, Withdrawn, Last updated: 30/03/2020
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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): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 2, 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): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , , Revision: 9, Authorised, Last updated: 18/03/2020
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Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, , Revision: 4, Authorised, Last updated: 06/03/2020
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Human medicine European public assessment report (EPAR): Praxbind
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, , Revision: 6, Authorised, Last updated: 05/03/2020
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Human medicine European public assessment report (EPAR): Mepsevii
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 3, Authorised, Last updated: 27/02/2020
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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): Evoltra
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, , Revision: 27, Authorised, Last updated: 05/02/2020
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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): Orphacol
cholic acid, Digestive System Diseases, Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 8, Authorised, Last updated: 27/01/2020
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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): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 10/01/2020
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,, , , Revision: 5, 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