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38 results
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,
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, 
, Revision: 18, Authorised, Last updated: 02/03/2021
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , , Revision: 13, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Lojuxta
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, , Revision: 13, Authorised, Last updated: 27/01/2021
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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: 10, Authorised, Last updated: 13/01/2021
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013,, , Revision: 18, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 5, Authorised, Last updated: 10/12/2020
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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: 24, Authorised, Last updated: 04/12/2020
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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: 29, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , , Revision: 7, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, , Revision: 6, Authorised, Last updated: 27/11/2020
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Human medicine European public assessment report (EPAR): Firdapse (previously Zenas)
amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009,, , Revision: 20, Authorised, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Mvabea
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Authorised, Last updated: 24/11/2020
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Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 3, Authorised, Last updated: 24/11/2020
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Human medicine European public assessment report (EPAR): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, , Revision: 17, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Mepsevii
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 5, Authorised, Last updated: 13/10/2020
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , , Revision: 13, Authorised, Last updated: 21/09/2020
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,, , , Revision: 6, Authorised, Last updated: 31/08/2020
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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,, , , Revision: 9, Authorised, Last updated: 11/08/2020
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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): 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,, 
, , , Revision: 4, Authorised, Last updated: 12/06/2020
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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): 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): 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): Vedrop
tocofersolan, Cholestasis, Vitamin E Deficiency
Date of authorisation: 23/07/2009,, , Revision: 13, Authorised, Last updated: 22/08/2019