385 results
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Human medicine European public assessment report (EPAR): Strimvelis (updated)
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,
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, Revision: 9, Authorised, Last updated: 19/09/2023
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , 
, Revision: 12, Authorised, Last updated: 29/08/2023
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Human medicine European public assessment report (EPAR): Luxturna
voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018,, , Revision: 7, Authorised, Last updated: 28/07/2023
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Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, , Revision: 10, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Kymriah
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 14, Authorised, Last updated: 10/05/2023
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Human medicine European public assessment report (EPAR): Spherox
spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases
Date of authorisation: 10/07/2017, Revision: 8, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Yescarta
Axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 11, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Imlygic
talimogene laherparepvec, Melanoma
Date of authorisation: 16/12/2015, Revision: 13, Authorised, Last updated: 15/12/2022 -
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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,, 
, , Revision: 5, Withdrawn, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Holoclar
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015,, , , Revision: 8, Authorised, Last updated: 06/01/2022
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Veterinary medicine European public assessment report (EPAR): Arti-Cell Forte
chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, Horses
Date of authorisation: 29/03/2019, Revision: 5, Authorised, Last updated: 25/10/2021 -
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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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Withdrawn application: OraNera
date of withdrawal: 14/03/2013, Initial authorisation, Last updated: 30/07/2013 -
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Referral: Maci
matrix applied characterised autologous cultured chondrocytes, associated names: Maci, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/09/2014, EC decision date: 19/11/2014, Last updated: 05/07/2018 -
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Referral: Fiprex
fipronil, Article 33
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 14/07/2014, Last updated: 14/08/2014 -
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Direct healthcare professional communication (DHPC): ZOLGENSMA (onasemnogene abeparvovec) - Fatal cases of acute liver failure
Active substance: Onasemnogene abeparvovec, DHPC type: Adverse event, Last updated: 17/02/2023 -
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Orphan designation: Human embryonic stem-cell-derived retinal pigment epithelial cells for: Treatment of Stargardt's disease
Date of designation: 21/06/2011, Withdrawn, Last updated: 19/07/2023 -
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Orphan designation: Citric acid monohydrate for: Treatment of acute liver failure
Date of designation: 27/06/2016, Positive, Last updated: 05/06/2023 -
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Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector encoding the human beta-globin gene for: Treatment of beta thalassaemia intermedia and major
Date of designation: 29/04/2009, Positive, Last updated: 24/03/2023 -
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Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene (betibeglogene autotemcel) for: Treatment of beta thalassaemia intermedia and major
Date of designation: 24/01/2013, Withdrawn, Last updated: 30/11/2022 -
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Orphan designation: Haematopoietic stem cells modified with a lentiviral vector containing the CD18 gene for: Treatment of leukocyte adhesion deficiency type I
Date of designation: 20/09/2016, Positive, Last updated: 11/11/2022 -
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Orphan designation: Radio-iodinated (131I) anti-CD45 murine monoclonal antibody for: Treatment in haematopoietic stem cell transplantation
Date of designation: 14/10/2016, Positive, Last updated: 14/09/2022 -
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Orphan designation: allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2, dexamethasone for: Treatment in haematopoietic stem cell transplantation
Date of designation: 18/11/2016, Withdrawn, Last updated: 10/08/2022 -
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Orphan designation: Human autologous mesenchymal adult stem cells extracted from adipose tissue for: Treatment of anal fistula
Date of designation: 26/08/2005, Withdrawn, Last updated: 01/07/2022 -
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Orphan designation: Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19 for: Treatment in haematopoietic stem cell transplantation
Date of designation: 27/06/2016, Withdrawn, Last updated: 07/04/2022