310 results
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,
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, Revision: 2, Authorised, Last updated: 19/04/2021
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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: 4, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, 
, , , Revision: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Strimvelis
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,, , Revision: 5, Authorised, Last updated: 28/01/2021
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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: 7, Authorised, Last updated: 14/01/2021
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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: 3, Authorised, Last updated: 05/01/2021
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Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, , Revision: 6, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Imlygic
talimogene laherparepvec, Melanoma
Date of authorisation: 16/12/2015, Revision: 8, Authorised, Last updated: 27/11/2020 -
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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: 3, Authorised, Last updated: 27/10/2020 -
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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: 4, Authorised, Last updated: 29/06/2020
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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: 6, Authorised, Last updated: 26/06/2020
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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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Orphan designation: Radio-iodinated (131I) anti-CD45 murine monoclonal antibody for: Treatment in haematopoietic stem cell transplantation
Date of first decision: 14/10/2016, Positive, Last updated: 09/04/2021 -
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Orphan designation: Allogeneic umbilical cord blood CD34+ cells cultured ex vivo with Notch ligand Delta1 (dilanubicel) for: Treatment in haematopoietic stem cell transplantation
Date of first decision: 17/01/2018, Withdrawn, Last updated: 22/03/2021 -
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Orphan designation: Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (darvadstrocel) for: Treatment of anal fistula
Date of first decision: 08/10/2009, Positive, Last updated: 26/08/2020 -
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Orphan designation: Ex-vivo-expanded autologous human corneal epithelium-containing stem cells for: Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns
Date of first decision: 07/11/2008, Positive, Last updated: 23/06/2020 -
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Orphan designation: Autologous adult bone marrow-derived non-expanded CD133+ haematopoietic stem cells for: Treatment of Asherman's syndrome
Date of first decision: 20/04/2017, Positive, Last updated: 31/03/2020 -
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Orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo for: Treatment of adenovirus infection in allogeneic haematopoietic stem cell transplant recipients
Date of first decision: 16/01/2014, Withdrawn, Last updated: 12/02/2020 -
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Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene for: The treatment of sickle cell disease
Date of first decision: 29/04/2014, Positive, Last updated: 13/01/2020 -
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Orphan designation: Human autologous bone-forming cells derived from bone marrow stem cells for: Treatment of non-traumatic osteonecrosis
Date of first decision: 29/10/2007, Withdrawn, Last updated: 20/11/2019 -
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Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene for: Treatment of beta thalassaemia intermedia and major
Date of first decision: 24/01/2013, Positive, Last updated: 03/06/2019 -
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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 first decision: 18/11/2016, Positive, Last updated: 17/05/2019