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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,
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, Revision: 5, Withdrawn, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Gamifant
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,
, Refused, Last updated: 23/03/2021
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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Date of authorisation: 14/05/2008,, Revision: 13, Withdrawn, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Zalmoxis
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
Date of authorisation: 18/08/2016,, Revision: 1, Withdrawn, Last updated: 14/02/2020
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Human medicine European public assessment report (EPAR): Lartruvo
Olaratumab, Sarcoma
Date of authorisation: 09/11/2016,, , , Revision: 3, Withdrawn, Last updated: 02/09/2019
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Human medicine European public assessment report (EPAR): Daklinza
daclatasvir dihydrochloride, Hepatitis C, Chronic
Date of authorisation: 22/08/2014,, Revision: 15, Withdrawn, Last updated: 30/08/2019
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Human medicine European public assessment report (EPAR): Alsitek
Masitinib mesilate, Amyotrophic Lateral Sclerosis
Date of refusal: 26/07/2018,, Refused, Last updated: 31/07/2018
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Human medicine European public assessment report (EPAR): Masipro
Masitinib mesilate, Mastocytosis
Date of refusal: 18/12/2017,, Refused, Last updated: 04/04/2018
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Human medicine European public assessment report (EPAR): Dropcys
mercaptamine, Corneal Diseases; Cystinosis
Date of refusal: 24/06/2016,, Refused, Last updated: 25/07/2016
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Human medicine European public assessment report (EPAR): Heparesc
Human heterologous liver cells, Urea Cycle Disorders, Inborn
Date of refusal: 21/12/2015,, Refused, Last updated: 04/04/2016
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Human medicine European public assessment report (EPAR): Lympreva
dasiprotimut-t, Lymphoma, Non-Hodgkin
Date of refusal: 03/07/2015,, Refused, Last updated: 17/07/2015
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Human medicine European public assessment report (EPAR): Masiviera
masitinib, Pancreatic Neoplasms, Refused, Last updated: 06/01/2015
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Human medicine European public assessment report (EPAR): Masican
masitinib, Gastrointestinal Stromal Tumors
Date of refusal: 04/07/2014,, Refused, Last updated: 22/11/2013
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Human medicine European public assessment report (EPAR): Istodax
romidepsin, Lymphoma, Non-Hodgkin
Date of refusal: 12/02/2013,, Refused, Last updated: 14/03/2013
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Human medicine European public assessment report (EPAR): Elelyso
Taliglucerase alfa, Gaucher Disease
Date of refusal: 25/10/2012,, Refused, Last updated: 23/11/2012
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Human medicine European public assessment report (EPAR): Folotyn
Pralatrexate, Lymphoma, T-Cell
Date of refusal: 21/06/2012,, Refused, Last updated: 11/07/2012
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Human medicine European public assessment report (EPAR): Arepanrix
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 23/03/2010,, Revision: 1, Withdrawn, Last updated: 25/10/2011
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Human medicine European public assessment report (EPAR): Humenza
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 08/06/2010,, Withdrawn, Last updated: 30/06/2011
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Human medicine European public assessment report (EPAR): Sovrima
idebenone, Friedreich Ataxia
Date of refusal: 27/04/2009,, Refused, Last updated: 31/12/2009
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Human medicine European public assessment report (EPAR): Mylotarg
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of refusal: 14/04/2008,, Refused, Last updated: 24/01/2008
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Human medicine European public assessment report (EPAR): Exondys
eteplirsen, Muscular Dystrophy, Duchenne
Date of refusal: 06/12/2018,, Refused, Last updated: 12/12/2018
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Human medicine European public assessment report (EPAR): Turalio
Pexidartinib, Giant Cell Tumor of Tendon Sheath; Synovitis, Pigmented Villonodular
Date of refusal: 28/10/2020,, , Refused, Last updated: 18/12/2020