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Medicine
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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,,
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, 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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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): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,,
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, Revision: 8, Authorised, Last updated: 28/01/2020
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Human medicine European public assessment report (EPAR): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,,
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, Revision: 10, Authorised, Last updated: 10/01/2020
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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): Iclusig
ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid
Date of authorisation: 01/07/2013,,
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, Revision: 20, Authorised, Last updated: 29/10/2019
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,,
, Revision: 10, Authorised, Last updated: 08/10/2019
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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): 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, Authorised, Last updated: 26/07/2019
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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: 6, Authorised, Last updated: 18/01/2019
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Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,,
, Revision: 12, Authorised, Last updated: 01/08/2018
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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,,
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, Revision: 3, Authorised, Last updated: 24/11/2017
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Human medicine European public assessment report (EPAR): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,,
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, Authorised, Last updated: 25/07/2017
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Human medicine European public assessment report (EPAR): Zabdeno
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,,
, Authorised, Last updated: 23/07/2020
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Human medicine European public assessment report (EPAR): Obiltoxaximab SFL
Obiltoxaximab, Anthrax
Date of authorisation: 18/11/2020,,
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, Authorised, Last updated: 27/11/2020
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Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,,
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, Authorised, Last updated: 25/01/2021