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Medicine
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Human medicine European public assessment report (EPAR): Ceplene (updated)
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,
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, Revision: 12, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Atriance (updated)
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, , Revision: 26, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, 
, , Revision: 23, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 12, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Ebvallo (updated)
Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022,, , , Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,, , Revision: 23, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, , Revision: 25, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Nyxthracis (previously Obiltoxaximab SFL)
nyxthracis, Anthrax
Date of authorisation: 18/11/2020,, , , Revision: 3, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Livmarli
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,, , , Authorised, Last updated: 14/12/2022
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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: 12, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , , Revision: 9, Authorised, Last updated: 04/11/2022
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,, , , Revision: 8, Authorised, Last updated: 27/10/2022
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Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 5, Authorised, Last updated: 27/10/2022
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Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 7, Authorised, Last updated: 27/10/2022
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Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, , Revision: 10, Authorised, Last updated: 26/10/2022
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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): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,
, , , Revision: 2, Authorised, Last updated: 05/10/2022
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Human medicine European public assessment report (EPAR): Upstaza
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , , Revision: 2, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Revision: 5, Authorised, Last updated: 23/09/2022
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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): Evoltra
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, , Revision: 31, Authorised, Last updated: 13/07/2022
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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): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 7, 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