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90 results
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Human medicine European public assessment report (EPAR): Evkeeza
Evinacumab, Hypercholesterolemia
Date of authorisation: 17/06/2021,
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, 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,, 
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, , Revision: 6, Authorised, Last updated: 16/08/2022
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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): 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): 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): 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): 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): ATryn
Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006,, , Revision: 16, Withdrawn, Last updated: 02/07/2019
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Human medicine European public assessment report (EPAR): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
Date of authorisation: 25/10/2012,, , Revision: 8, Withdrawn, Last updated: 30/10/2017
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Human medicine European public assessment report (EPAR): Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) , Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 04/03/2011,, Revision: 4, Withdrawn, Last updated: 17/03/2015
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Human medicine European public assessment report (EPAR): Daronrix
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 21/03/2007,, Withdrawn, Last updated: 02/07/2013
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Human medicine European public assessment report (EPAR): Rilonacept Regeneron (previously Arcalyst)
Rilonacept, Cryopyrin-Associated Periodic Syndromes
Date of authorisation: 23/10/2009,, Revision: 5, Withdrawn, Last updated: 30/10/2012
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Veterinary medicine European public assessment report (EPAR): Poulvac Flufend H5N3 RG
recombinant inactivated avian influenza virus, Chicken; Ducks
Date of authorisation: 01/09/2006,, , Revision: 8, Withdrawn, Last updated: 07/05/2012
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Human medicine European public assessment report (EPAR): Xigris
drotrecogin alfa (activated), Sepsis; Multiple Organ Failure
Date of authorisation: 22/08/2002,, Revision: 13, Withdrawn, Last updated: 21/02/2012
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Human medicine European public assessment report (EPAR): Onsenal
Celecoxib, Adenomatous Polyposis Coli
Date of authorisation: 17/10/2003,, Revision: 13, Withdrawn, Last updated: 06/04/2011
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N6
inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), Chicken
Date of authorisation: 31/01/2008,, , Revision: 1, Withdrawn, Last updated: 26/07/2010
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H7N1
inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), Chicken; Ducks
Date of authorisation: 14/05/2007,, , Revision: 2, Withdrawn, Last updated: 26/07/2010
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Withdrawn application: Evoltra
clofarabine, date of withdrawal: 18/03/2008, Post-authorisation, Last updated: 19/03/2008 -
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Referral: Factor VIII
associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017