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004480/0098/m1/eu/10-cover/ema/ema-cover.pdf 903 KB
004480/0098/m1/eu/10-cover/ema/ema-tracking.pdf 123 KB
004480/0098/m1/eu/12-form/ema/ema-form-eaf.pdf 392 KB
004480/0098/m1/eu/12-form/ema/ema-form-annex-var-guidance.pdf 53 KB
004480/0098/m1/eu/12-form/ema/ema-form-annex-mla.pdf 584 KB
004480/0098/m1/eu/12-form/ema/ema-form-annex-present-proposed.pdf 382 KB
004480/0098/m1/eu/12-form/ema/ema-form-annex-comp-tables.pdf 69 KB
004480/0098/m1/eu/12-form/ema/ema-form-annex-orphanec.pdf 45 KB
004480/0098/m1/eu/12-form/ema/ema-form-annex-514-pei-fahmp.pdf 90 KB
004480/0098/m1/eu/13-pi/131-spclabelpl/ema/en/ema-combined-h-4480-en.pdf 650 KB
004480/0098/m1/eu/13-pi/134-consultation/ema/ema-consultation-zuma-5.pdf 60 KB
004480/0098/m1/eu/14-expert/142-nonclinical/nonclinical.pdf 633 KB
004480/0098/m1/eu/14-expert/143-clinical/clinical.pdf 433 KB
004480/0098/m1/eu/15-specific/153-data-market-exclusivity/datamarketexclusivity-zuma-5.pdf 429 KB
004480/0098/m1/eu/16-environrisk/162-gmo/gmo.pdf 16.4 MB
004480/0098/m1/eu/16-environrisk/162-gmo/gmo-expert-signature-cv.pdf 276 KB
004480/0098/m1/eu/17-orphan/171-similarity/similarity-report-gazyvaro.pdf 100 KB
004480/0098/m1/eu/17-orphan/172-market-exclusivity/marketexclusivity-zuma-5.pdf 55 KB
004480/0098/m1/eu/18-pharmacovigilance/182-riskmgt-system/riskmgtsystem.pdf 11 MB
004480/0098/m1/eu/19-clinical-trials/clinicaltrials-zuma-5.pdf 58 KB
004480/0098/m1/eu/110-paediatrics/paediatrics-p-0132-2020.pdf 482 KB
004480/0098/m2/22-intro/introduction-zuma-5.pdf 76 KB
004480/0098/m2/24-nonclin-over/nonclinical-overview-zuma-5.pdf 437 KB
004480/0098/m2/25-clin-over/clinical-overview-zuma-5.pdf 1.2 MB
004480/0098/m2/26-nonclin-sum/introduction-zuma-5.pdf 604 KB
004480/0098/m2/26-nonclin-sum/toxicology-written-summary-zuma-5.pdf 157 KB
004480/0098/m2/26-nonclin-sum/toxicology-tabulated-summary-zuma-5.pdf 104 KB
004480/0098/m2/27-clin-sum/summary-biopharm-zuma-5.pdf 95 KB
004480/0098/m2/27-clin-sum/summary-clin-pharm-zuma-5.pdf 820 KB
004480/0098/m2/27-clin-sum/summary-clin-efficacy-zuma-5.pdf 1.7 MB
004480/0098/m2/27-clin-sum/summary-clin-safety-zuma-5.pdf 741 KB
004480/0098/m2/27-clin-sum/literature-references-zuma-5.pdf 101 KB
004480/0098/m2/27-clin-sum/synopses-indiv-studies-zuma-5.pdf 92 KB
004480/0098/m4/42-stud-rep/423-tox/4233-genotox/42332-in-vivo/4-2-3-3-2/report.pdf 1.1 MB
004480/0098/m4/43-lit-ref/biasco-2011-embomolmed.pdf 787 KB
004480/0098/m4/43-lit-ref/chang-2016-molther.pdf 2.9 MB
004480/0098/m4/43-lit-ref/cooper-2003-blood.pdf 572 KB
004480/0098/m4/43-lit-ref/finney-1998-jimmunol.pdf 96 KB
004480/0098/m4/43-lit-ref/fraietta-2018-nature.pdf 3.6 MB
004480/0098/m4/43-lit-ref/johnson-2009-blood.pdf 332 KB
004480/0098/m4/43-lit-ref/kochenderfer-2009-jimmunother.pdf 787 KB
004480/0098/m4/43-lit-ref/kochenderfer-2010-blood.pdf 656 KB
004480/0098/m4/43-lit-ref/kochenderfer-2017-jclinoncol.pdf 1 MB
004480/0098/m4/43-lit-ref/kochenderfer-2017-molther.pdf 804 KB
004480/0098/m4/43-lit-ref/leonard-2001-curropinoncol.pdf 283 KB
004480/0098/m4/43-lit-ref/locke-2019-lancetoncol.pdf 135 KB
004480/0098/m4/43-lit-ref/neelapu-2017-nengljmed.pdf 388 KB
004480/0098/m4/43-lit-ref/nicholson-1997-molimmunol.pdf 674 KB
004480/0098/m4/43-lit-ref/olejniczak-2006-immunolinvest.pdf 302 KB
004480/0098/m4/43-lit-ref/restifo-2012-natrevimmunol.pdf 1.2 MB
004480/0098/m4/43-lit-ref/rodriguez-1994-hematoloncol.pdf 268 KB
004480/0098/m4/43-lit-ref/shah-2019-bloodadv.pdf 1014 KB
004480/0098/m4/43-lit-ref/uckun-1988-blood.pdf 1.2 MB
004480/0098/m4/43-lit-ref/zola-1988-immunolcellbiol.pdf 3.1 MB
004480/0098/m4/43-lit-ref/zola-1989-immunology.pdf 553 KB
004480/0098/m4/43-lit-ref/zola-1991-immunolcellbiol.pdf 2.5 MB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/study-report-5314/method-val-5314-zuma-5.pdf 403 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/study-report-5314/method-val-5314-zuma-5-add.pdf 108 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/bioagilytix-bal-19-187-064-rep/method-val-bal-19-187-064-rep.pdf 3.6 MB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/bioagilytix-bal-20-187-063-rep/method-val-bal-20-187-063-rep.pdf 721 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/bioagilytix-baeu-18-187-051baeu-19-187-05506301-rep/method-val-baeu-19-187-055-051-063-rep.pdf 299 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/bioagilytix-baeu-18-187-051baeu-19-187-05506301-rep/method-val-baeu-18-187-051-19-187-055-06301-amend1.pdf 545 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/intertek-ar-17-0175/method-val-intertek-ar-17-0175.pdf 4.4 MB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0279/method-val-neogenomics-phar-valr-0279.pdf 2 MB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0315/method-val-neogenomics-phar-valr-0315.pdf 117 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0334/method-val-neogenomics-phar-valr-0334.pdf 117 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0354/method-val-neogenomics-phar-valr-0354.pdf 118 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0415/method-val-neogenomics-phar-valr-0415.pdf 107 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0417/method-val-neogenomics-phar-valr-0417.pdf 157 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0425/method-val-neogenomics-phar-valr-0425.pdf 1.8 MB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0426/method-val-neogenomics-phar-valr-0426.pdf 1.9 MB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0427/method-val-neogenomics-phar-valr-0427.pdf 1.3 MB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-valr-0430/method-val-neogenomics-phar-valr-0430.pdf 1.8 MB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-phar-verr-0019/method-val-neogenomics-phar-verr-0019.pdf 2.2 MB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/neogenomics-tmf-ssp-0203/method-val-neogenomics-tmf-ssp-0203.pdf 220 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/urmc-c19-001/method-val-urmc-c19-001.pdf 190 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/urmc-c19-002/method-val-urmc-c19-002.pdf 185 KB
004480/0098/m5/53-clin-stud-rep/531-rep-biopharm-stud/5314-bioanalyt-analyt-met/urmc-sh-cp-ct-val-0026-0001a/method-val-urmc-sh-cp-ct-val-0026-0001a.pdf 1.2 MB
004480/0098/m5/53-clin-stud-rep/534-rep-human-pd-stud/5342-patient-pd-stud-rep/kte-c19-105-pk-pd/report-body.pdf 26.7 MB
004480/0098/m5/53-clin-stud-rep/534-rep-human-pd-stud/5342-patient-pd-stud-rep/kte-c19-105-pk-pd/statistical-methods.pdf 289 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5351-stud-rep-contr/scholar-5/scholar-5-report-body.pdf 2.2 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5351-stud-rep-contr/scholar-5/scholar-5-protocol.pdf 330 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5351-stud-rep-contr/scholar-5/scholar-5-statistical-methods.pdf 2.3 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/synopsis.pdf 126 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/report-body.pdf 33.9 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/protocol.pdf 5.6 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/sample-crf.pdf 2.3 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/iec-irb-list.pdf 410 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/investigator-list.pdf 128 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/signatures-investigators.pdf 201 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/patient-list-by-batch.pdf 149 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/audit-certificates.pdf 469 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/statistical-methods.pdf 2.5 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/list-discontinued-pts.pdf 67 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/list-protocol-deviations.pdf 186 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/list-pts-excluded-efficacy.pdf 200 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/list-demographic-data.pdf 303 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/list-comply-or-concentration.pdf 232 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/list-efficacy-response.pdf 4.5 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/list-adverse-events.pdf 18.1 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105/list-labs-by-pts.pdf 39.5 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/synopsis.pdf 150 KB
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004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/narratives.pdf 6.5 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/protocol.pdf 2 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/sample-crf.pdf 4 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/iec-irb-list.pdf 343 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/investigator-list.pdf 112 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/signatures-investigators.pdf 202 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/patient-list-by-batch.pdf 161 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/statistical-methods.pdf 5 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/list-discontinued-pts.pdf 43 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/list-protocol-deviations.pdf 344 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/list-pts-excluded-efficacy.pdf 208 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/list-demographic-data.pdf 328 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/list-comply-or-concentration.pdf 156 KB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/list-efficacy-response.pdf 5.2 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/list-adverse-events.pdf 28.3 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5352-stud-rep-uncontr/kte-c19-105-addendum/list-labs-by-pts.pdf 36.6 MB
004480/0098/m5/53-clin-stud-rep/535-rep-effic-safety-stud/rr-inhl/5353-rep-analys-data-more-one-stud/iss/iss-tfls.pdf 20 MB
004480/0098/m5/54-lit-ref/aliqopa-2020-uspi.pdf 396 KB
004480/0098/m5/54-lit-ref/andorsky-2019-jclinoncol-abstract.pdf 2.1 MB
004480/0098/m5/54-lit-ref/barr-2017-blood.pdf 548 KB
004480/0098/m5/54-lit-ref/batlevi-2020-bloodcancerj.pdf 1.3 MB
004480/0098/m5/54-lit-ref/bendamustinehydrochloride-2021-smpc.pdf 463 KB
004480/0098/m5/54-lit-ref/bendeka-2020-uspi.pdf 183 KB
004480/0098/m5/54-lit-ref/blincyto-2020-uspi.pdf 435 KB
004480/0098/m5/54-lit-ref/brudno-2018-natrevclinoncol.pdf 824 KB
004480/0098/m5/54-lit-ref/casulo-2015-jclinoncol.pdf 159 KB
004480/0098/m5/54-lit-ref/chang-2019-asgct-presentation.pdf 999 KB
004480/0098/m5/54-lit-ref/cheah-2018-bestpractresclinhaematol.pdf 216 KB
004480/0098/m5/54-lit-ref/cheson-2014-jclinoncol.pdf 134 KB
004480/0098/m5/54-lit-ref/cheson-2018-jclinoncol.pdf 915 KB
004480/0098/m5/54-lit-ref/copiktra-2019-uspi.pdf 7.8 MB
004480/0098/m5/54-lit-ref/copiktra-2021-smpc.pdf 524 KB
004480/0098/m5/54-lit-ref/dada-2019-eurjhaematol.pdf 509 KB
004480/0098/m5/54-lit-ref/denlinger-2018-cancermanagementres.pdf 176 KB
004480/0098/m5/54-lit-ref/dreyling-2017-jclinoncol.pdf 851 KB
004480/0098/m5/54-lit-ref/ekberg-2020-brjhaematol.pdf 1.2 MB
004480/0098/m5/54-lit-ref/evens-2013-cancer.pdf 255 KB
004480/0098/m5/54-lit-ref/fenske-2018-ascopost.pdf 614 KB
004480/0098/m5/54-lit-ref/flinn-2019-jclinoncol.pdf 1.6 MB
004480/0098/m5/54-lit-ref/freedman-2018-amjhematol.pdf 665 KB
004480/0098/m5/54-lit-ref/friedberg-2012-jclinoncol.pdf 241 KB
004480/0098/m5/54-lit-ref/garfall-2015-nengljmed.pdf 1.2 MB
004480/0098/m5/54-lit-ref/gazyva-2017-uspi.pdf 795 KB
004480/0098/m5/54-lit-ref/gazyva-2021-uspi.pdf 674 KB
004480/0098/m5/54-lit-ref/gazyvaro-2014-smpc.pdf 913 KB
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004480/0098/m5/54-lit-ref/gust-2017-cancerdiscov.pdf 1.6 MB
004480/0098/m5/54-lit-ref/hajek-2013-brjhaematol.pdf 419 KB
004480/0098/m5/54-lit-ref/imbruvica-2020-uspi.pdf 1.1 MB
004480/0098/m5/54-lit-ref/italiano-2018-lancetoncol.pdf 268 KB
004480/0098/m5/54-lit-ref/kahl-2008-hematologyamsoc.pdf 98 KB
004480/0098/m5/54-lit-ref/kahl-2016-blood.pdf 901 KB
004480/0098/m5/54-lit-ref/kritharis-2015-cancertreatres.pdf 308 KB
004480/0098/m5/54-lit-ref/kuperhommel-2013-leuklymphoma.pdf 652 KB
004480/0098/m5/54-lit-ref/kurth-2006-amjepidemiol.pdf 119 KB
004480/0098/m5/54-lit-ref/lee-2011-annalsofoncology.pdf 280 KB
004480/0098/m5/54-lit-ref/leguyaderpeyrou-2016-revepidemiolsantepublique.pdf 263 KB
004480/0098/m5/54-lit-ref/leonard-2019-jclinoncol.pdf 1.5 MB
004480/0098/m5/54-lit-ref/li-2013-exprevofanticancerther.pdf 1014 KB
004480/0098/m5/54-lit-ref/link-2019-brjhaematol.pdf 161 KB
004480/0098/m5/54-lit-ref/locke-2018-asco-abstract.pdf 689 KB
004480/0098/m5/54-lit-ref/luminari-2007-hematoloncol.pdf 237 KB
004480/0098/m5/54-lit-ref/luminari-2019-blood.pdf 680 KB
004480/0098/m5/54-lit-ref/lunning-2016-brjhaematol.pdf 106 KB
004480/0098/m5/54-lit-ref/mangal-2017-hematologicaloncol.pdf 384 KB
004480/0098/m5/54-lit-ref/maurer-2014-journalofclinicaloncology.pdf 239 KB
004480/0098/m5/54-lit-ref/maurer-2016-amjhematol.pdf 696 KB
004480/0098/m5/54-lit-ref/mclaughlin-1991-annoncol.pdf 354 KB
004480/0098/m5/54-lit-ref/mclaughlin-1998-jclinoncol.pdf 480 KB
004480/0098/m5/54-lit-ref/miller-2015-clincancerres.pdf 148 KB
004480/0098/m5/54-lit-ref/morschhauser-2019-blood-abstract.pdf 633 KB
004480/0098/m5/54-lit-ref/noy-2017-blood.pdf 774 KB
004480/0098/m5/54-lit-ref/revlimid-2019-smpc.pdf 713 KB
004480/0098/m5/54-lit-ref/revlimid-2019-uspi.pdf 893 KB
004480/0098/m5/54-lit-ref/robinson-2013-bonemarrowtransplant.pdf 327 KB
004480/0098/m5/54-lit-ref/sant-2010-blood.pdf 386 KB
004480/0098/m5/54-lit-ref/santomasso-2018-cancerdiscov.pdf 1.7 MB
004480/0098/m5/54-lit-ref/sehn-2016-lancetoncol.pdf 148 KB
004480/0098/m5/54-lit-ref/shi-2017-jclinoncol.pdf 839 KB
004480/0098/m5/54-lit-ref/sindel-2019-currtreatoptionsoncol.pdf 219 KB
004480/0098/m5/54-lit-ref/solal-celigny-2004-blood.pdf 303 KB
004480/0098/m5/54-lit-ref/tan-2013-blood.pdf 735 KB
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004480/0098/m5/54-lit-ref/teixeiramendes-2017-bestpractresclinhaematol.pdf 6.8 MB
004480/0098/m5/54-lit-ref/thenonhodgkinslymphclassproj-1997-blood.pdf 179 KB
004480/0098/m5/54-lit-ref/thieblemont-2019-eha-posterps1262.pdf 789 KB
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004480/0098-workingdocuments/2.7.6 Synopses of Individual Studies - ZUMA-5.docx 43 KB
004480/0098-workingdocuments/2.6.1 Introduction - ZUMA-5.docx 707 KB
004480/0098-workingdocuments/2.6.7 Toxicology Tabulated Summary - ZUMA-5.docx 79 KB
004480/0098-workingdocuments/1.8.2 Risk Management System Annex 3.docx 38 KB
004480/0098-workingdocuments/2.7.4 Summary of Clinical Safety - ZUMA-5.docx 485 KB
004480/0098-workingdocuments/2.7.2 Summary of Clinical Pharmacology Studies - ZUMA-5.docx 651 KB
004480/0098-workingdocuments/ema-combined-h-4480-en-annotated.docx 244 KB
004480/0098-workingdocuments/1.8.2 Risk Management System Annex 6 - Annotated.docx 134 KB
004480/0098-workingdocuments/ema-combined-h-4480-en.docx 227 KB
004480/0098-workingdocuments/2.6.6 Toxicology Written Summary - ZUMA-5.docx 194 KB
004480/0098-workingdocuments/2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods - ZUMA-5.docx 76 KB
004480/0098-workingdocuments/2.5 Clinical Overview - ZUMA-5.docx 2.8 MB
004480/0098-workingdocuments/2.4 Nonclinical Overview - ZUMA-5.docx 765 KB
004480/0098-workingdocuments/1.8.2 Risk Management System Annex 3 - Annotated.docx 39 KB
004480/0098-workingdocuments/1.8.2 Risk Management System - Annotated.docx 1.9 MB
004480/0098-workingdocuments/1.8.2 Risk Management System Annex 2 - Annotated.docx 40 KB
004480/0098-workingdocuments/1.8.2 Risk Management System Annex 2.docx 38 KB
004480/0098-workingdocuments/2.2 Introduction - ZUMA-5.docx 62 KB
004480/0098-workingdocuments/2.7.3 Summary of Clinical Efficacy - ZUMA-5.docx 2.1 MB
004480/0098-workingdocuments/2.7.5 Literature References - ZUMA-5.docx 51 KB
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