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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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IM-MV 18-005_000
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Universitair Medisch Centrum Utrecht
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Clinical development program for a gene replacement therapy for patients with Spinal Muscular Atrophy utilizing AVXS-101, an adeno-associated viral vector serotype 2/9 containing the human SMN gene.
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13-05-2019
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Vergunning verleend
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IM-MV 18-013_000
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UMCG
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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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Ontwerpbesluit genomen
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IM-MV 19-002_000
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Universitair Medisch Centrum Utrecht
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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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Ontwerpbesluit genomen
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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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Ontwerpbesluit genomen
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IM-MV 19-007_000
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Het Nederlands Kanker Instituut
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An open-label, Phase I/II multicenter clinical trial of VXM01 in combination with avelumab in patients with progressive glioblastoma and further clinical studies with VXM01 in patients with solid malignancies
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Ontwerpbesluit genomen
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