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C/NL/06/01_001
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Suntory Flowers Limited
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Application for renewal of consent for marketing approval under Directive 2001/18/EC (Event FLORIGENE®Moonaqua™(FLO-4Ø689-6))
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09-11-2018
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Vergunning verleend
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C/NL/13/02/00
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Suntory Holdings
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Application to import cut-flowers of carnation (Dianthus caryophyllus) line FLO-40685-2 for distribution and retail under directive 2001/18/EC
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05-09-2019
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Vergunning verleend
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IM 11-003_009
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LUMC
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Toediening van donor virus-specifieke T-cellen die ex vivo getransduceerd zijn met een retrovirale vector coderend voor leukemie-specifieke TCR, als behandeling na allogene stamceltransplantatie voor patiënten met refractaire of recidief hematologische maligniteiten
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28-08-2019
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Vergunning verleend
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IM-MV 18-014_000
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LUMC
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RAG1‐SCID and RAG2‐SCID CD34+ gene therapy using 3rd generation self‐inactivating (SIN)‐lentiviral vector
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16-08-2019
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Vergunning verleend
|
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IM-MV 19-004_000
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Erasmus MC
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Clinical testing of MC2 TCR T cells, an autologous cellular immunotherapy composed of autologous T cells genetically modified ex vivo to express a T cell receptor (TCR) that, upon reinfusion into the patient, recognize and kill MAGE-C2 (MC2)-expressing tumor cells
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27-08-2019
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Vergunning verleend
|
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IM-MV 19-005_000
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Erasmus MC
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Phase III study testing bb2121, consisting of autologous T lymphocytes ex-vivo transduced by a replication-defective lentiviral vector to express anti-BCMA chimeric antigen receptors (CAR) to target tumor cells expressing the human B cell maturation antigen (BCMA), in patients with relapsed and refractory multiple myeloma (RRMM)
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16-08-2019
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Vergunning verleend
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IM-MV 19-008_000
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Het Nederlands Kanker Instituut
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Clinical Trials to Assess the Safety and/or Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells (GSK3377794), alone or in combination with other agents, in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 Participants with NY-ESO-1 and/or LAGE-1a Positive Cancers
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|
Ontwerpbesluit genomen
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IM-MV 19-009_000
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Erasmus MC
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A Phase III, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Patients with Malignant Pleural Mesothelioma
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Ontwerpbesluit genomen
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IM-MV 19-010_000
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Universitair Medisch Centrum Utrecht
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A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-seropositive Donors (D+)
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27-08-2019
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Vergunning verleend
|
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IM-MV 19-011_000
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Erasmus MC
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Clinical testing of JNJ-68284528, composed of autologous T cells genetically modified with a lentiviral vector (LVV) to express a chimeric antigen receptor (CAR) that, upon reinfusion into the patient, recognize and kill B-cell maturation antigen (BCMA)-expressing tumour cells
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04-09-2019
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Vergunning verleend
|
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IM-MV 19-012_000
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VU medisch centrum
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Clinical testing of JNJ-68284528, composed of autologous T cells genetically modified with a lentiviral vector (LVV) to express a chimeric antigen receptor (CAR) that, upon reinfusion into the patient, recognize and kill B-cell maturation antigen (BCMA)-expressing tumor cells
|
04-09-2019
|
Vergunning verleend
|
|
IM-MV 19-013_000
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LUMC
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A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-seropositive Donors (D+)
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28-08-2019
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Vergunning verleend
|
|
IM-MV 19-015_000
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VU medisch centrum
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Clinical trials testing bb2121, consisting of autologous T lymphocytes ex-vivo transduced by a replication-defective lentiviral vector to express anti-BCMA chimeric antigen receptors (CAR) to target tumor cells expressing the human B cell maturation antigen (BCMA), in patients with multiple myeloma
|
|
Ontwerpbesluit genomen
|
|
IM-MV 19-017_000
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Universitair Medisch Centrum Utrecht
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Clinical Trials to Assess the Safety and/or Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells (GSK3377794), alone or in combination with other agents, in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 Participants with NY-ESO-1 and/or LAGE-1a Positive Cancers
|
|
Ontwerpbesluit genomen
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