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133 results
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Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,
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, Revision: 10, Authorised, Last updated: 26/10/2022
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Human medicine European public assessment report (EPAR): Iclusig
Ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,
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, Revision: 24, Authorised, Last updated: 21/10/2022
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Human medicine European public assessment report (EPAR): Vpriv
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, Revision: 19, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 42, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Evkeeza
Evinacumab, Hypercholesterolemia
Date of authorisation: 17/06/2021,, , Revision: 2, Authorised, Last updated: 12/10/2022
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , , , Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 20, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Vidaza
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 25, Authorised, Last updated: 14/06/2022
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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: 11, Authorised, Last updated: 08/06/2022
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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: 21, Authorised, Last updated: 25/05/2022
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 22, Authorised, Last updated: 26/04/2022
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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: 12, Authorised, Last updated: 06/04/2022
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Human medicine European public assessment report (EPAR): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,, , , Revision: 1, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , Revision: 13, Authorised, Last updated: 02/02/2022
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Human medicine European public assessment report (EPAR): Voraxaze
glucarpidase, Metabolic Side Effects of Drugs and Substances
Date of authorisation: 11/01/2022,, , , Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Increlex
Mecasermin, Laron Syndrome
Date of authorisation: 02/08/2007,, , Revision: 24, Authorised, Last updated: 11/01/2022
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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,, , Revision: 2, Authorised, Last updated: 10/01/2022
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Human medicine European public assessment report (EPAR): Mepsevii
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 6, Authorised, Last updated: 06/01/2022
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,, , , Revision: 5, Authorised, Last updated: 15/12/2021
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Human medicine European public assessment report (EPAR): Dectova
Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019,, , Revision: 4, Authorised, Last updated: 08/10/2021
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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: 07/06/2021
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2
inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), Chicken
Date of authorisation: 01/09/2006,, Revision: 8, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Prepandrix
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 14/05/2008,, Revision: 13, Withdrawn, Last updated: 23/02/2021
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Veterinary medicine European public assessment report (EPAR): Bluevac BTV (previously known as Bluevac BTV8)
bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated], Sheep; Cattle
Date of authorisation: 14/04/2011,, Revision: 7, Authorised, Last updated: 27/10/2020
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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