266 results
Keyword Glicerolo Zeta Remove keyword
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Human medicine European public assessment report (EPAR): Retacrit
epoetin zeta, Anemia; Blood Transfusion, Autologous; Kidney Failure, Chronic; Cancer
Date of authorisation: 18/12/2007,
, Revision: 30, Authorised, Last updated: 14/12/2022
Authorised epoetin zeta Overview This is a summary … active substance , epoetin zeta. Retacrit is a ‘biosimilar’ … substance in Retacrit, epoetin zeta, is a copy of human erythropoietin … -
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Human medicine European public assessment report (EPAR): Silapo
epoetin zeta, Anemia; Blood Transfusion, Autologous; Cancer; Kidney Failure, Chronic
Date of authorisation: 18/12/2007,, Revision: 17, Authorised, Last updated: 25/11/2020
epoetin zeta … efficacy and safety of Epoetin zeta have not been demonstrated … substance in SB309 (Epoetin zeta) is a recombinant human erythropoietin … -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of acute lymphoblastic leukaemia
Date of designation: 11/11/2015, Withdrawn, Last updated: 12/01/2022encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of mantle cell lymphoma
Date of designation: 09/10/2015, Withdrawn, Last updated: 12/01/2022encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
Date of designation: 11/11/2015, Withdrawn, Last updated: 12/01/2022encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Orphan designation: Autologous T-cells transduced with lentiviral vector encoding an anti-SLAMF7 CD28/CD3-zeta chimeric antigen receptor for: Treatment of plasma cell myeloma
Date of designation: 27/02/2017, Positive, Last updated: 31/03/2017encoding an anti-SLAMF7 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-SLAMF7 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-SLAMF7 CD28/CD3-zeta chimeric antigen receptor … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002335-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/08/2018, Last updated: 17/01/2019, Compliance check: Xencoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of diffuse large B-cell lymphoma
Date of designation: 16/12/2014, Positive, Last updated: 16/12/2022encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor … -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of follicular lymphoma
Date of designation: 11/11/2015, Positive, Last updated: 12/07/2022encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of primary mediastinal large B-cell lymphoma
Date of designation: 09/10/2015, Positive, Last updated: 15/09/2021encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains for: Treatment of multiple myeloma
Date of designation: 04/06/2020, Positive, Last updated: 19/08/2020antigen with 4-1BB and CD3-zeta intracellular signalling … antigen with 4-1BB and CD3-zeta intracellular signalling … -
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Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human claudin 18.2 antigen with CD28 and CD3-zeta intracellular signalling domains for: Treatment of gastric cancer
Date of designation: 19/02/2021, Positive, Last updated: 23/02/2022antigen with CD28 and CD3-zeta intracellular signalling … antigen with CD28 and CD3-zeta intracellular signalling … -
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Human medicine European public assessment report (EPAR): Tecartus
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,
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, Revision: 4, Authorised, Last updated: 30/01/2023
expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Orphan designation: Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) for: Treatment of acute lymphoblastic leukaemia
Date of designation: 19/10/2020, Positive, Last updated: 02/12/2022expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor … expressing anti-CD19 CD28/CD3- zeta chimeric antigen receptor … expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Orphan designation: autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) for: Treatment of mantle cell lymphoma
Date of designation: 13/11/2019, Positive, Last updated: 15/09/2021expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor … expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor … expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains (idecabtagene vicleucel) for: Treatment of multiple myeloma
Date of designation: 20/04/2017, Positive, Last updated: 03/12/2021antigen with 4-1BB and CD3-zeta intracellular signalling … antigen with 4-1BB and CD3-zeta intracellular signalling … antigen with 4-1BB and CD3-zeta intracellular signalling … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001862-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 06/12/2019, Last updated: 31/03/2020, Compliance check: Xexpressing anti CD19 CD28/CD3-zeta chimeric antigen receptor … expressing anti CD19 CD28/CD3-zeta chimeric PDF icon application/pdf … expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains (CT053)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002823-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Suspension for infusion
Decision date: 23/10/2020, Last updated: 22/07/2021, Compliance check: Xantigen with 4-1BB and CD3-zeta intracellular signalling … antigen with 4-1BB and CD3-zeta intracellular signalling … antigen with 4-1BB and CD3-zeta intracellular signalling … -
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National expert: Dimitar Roussinov, Bulgarian Drug Agency (updated)
- Declaration of interests - 81.03 KB | PDF
- Curriculum Vitae - 18.3 KB | PDF
Limited Retacrit (epoetin zeta) Post-Autorization Safety … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001862-PIP01-15-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 18/04/2020, Last updated: 08/03/2021, Compliance check: Xexpressing anti CD19 CD28/CD3-zeta chimeric antigen receptor … expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor … expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
PIP number: EMEA-001862-PIP03-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 05/01/2021, Last updated: 29/09/2021, Compliance check: Xexpressing anti CD19 CD28/CD3-zeta chimeric antigen receptor … expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor … expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor … -
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Press release: EMEA recommends a new warning for epoetins for their use in cancer patients
CHMP, Last updated: 26/06/2008Retacrit and Silapo (epoetin zeta) and Abseamed, Binocrit and … Retacrit and Silapo (epoetin zeta) and Abseamed, Binocrit and … -
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National expert: Sayeh Ahrabi, Norwegian Medicines Agency (updated)
- Declaration of interests - 80.05 KB | PDF
- Curriculum Vitae - 18.39 KB | PDF
phospholipids and its relation to zeta potential variations. Thesis … -
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National expert: Giuseppe Costante, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.3 KB | PDF
- Curriculum Vitae - 51.84 KB | PDF
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National expert: Pia Isomäki, European Medicines Agency (updated)
- Declaration of interests - 81.64 KB | PDF
- Curriculum Vitae - 23.8 KB | PDF
Y, Cope A. T cell receptor zeta reconstitution fails to …