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002498

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002498/0000/m1/eu/10-cover/emea/emea-cover.pdf 126 KB
002498/0000/m1/eu/10-cover/emea/emea-cover-appendix.pdf 611 KB
002498/0000/m1/eu/10-cover/emea/emea-cover-sequence.pdf 62 KB
002498/0000/m1/eu/12-form/emea/emea-form.pdf 2.5 MB
002498/0000/m1/eu/12-form/emea/emea-form-annex53.pdf 3.7 MB
002498/0000/m1/eu/12-form/emea/emea-form-annex54.pdf 453 KB
002498/0000/m1/eu/12-form/emea/emea-form-annex55.pdf 2.5 MB
002498/0000/m1/eu/12-form/emea/emea-form-annex56.pdf 1.4 MB
002498/0000/m1/eu/12-form/emea/emea-form-annex58.pdf 59 KB
002498/0000/m1/eu/12-form/emea/emea-form-annex59hi.pdf 724 KB
002498/0000/m1/eu/12-form/emea/emea-form-annex59sumka.pdf 508 KB
002498/0000/m1/eu/12-form/emea/emea-form-annex5142007.pdf 379 KB
002498/0000/m1/eu/12-form/emea/emea-form-annex5142008.pdf 379 KB
002498/0000/m1/eu/12-form/emea/emea-form-annex5142009.pdf 1.9 MB
002498/0000/m1/eu/12-form/emea/emea-form-netherlands.pdf 281 KB
002498/0000/m1/eu/12-form/emea/emea-form-annex5142010.pdf 783 KB
002498/0000/m1/eu/12-form/emea/emea-form-annex517.pdf 112 KB
002498/0000/m1/eu/12-form/emea/emea-form-annex522.pdf 3.3 MB
002498/0000/m1/eu/13-pi/131-spclabelpl/emea/en/emea-combined-h2498en.pdf 4.4 MB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-labeluk.pdf 79 KB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-labelbe.pdf 79 KB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-cartonuk.pdf 1.3 MB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-cartonbe.pdf 1.3 MB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-leaflet.pdf 4.7 MB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-labeluk200.pdf 78 KB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-labelbe200.pdf 79 KB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-cartonuk200.pdf 1 MB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-cartonbe200.pdf 1 MB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-leaflet200.pdf 4.7 MB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-labelukpen100.pdf 77 KB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-labelbepen.pdf 77 KB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-cartonuk100pen.pdf 111 KB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-cartonbe100pen.pdf 117 KB
002498/0000/m1/eu/13-pi/132-mockup/emea/emea-mockup-leafletpen.pdf 126 KB
002498/0000/m1/eu/13-pi/134-consultation/emea/emea-consultation-readability.pdf 668 KB
002498/0000/m1/eu/13-pi/134-consultation/emea/emea-consultation-pil200flex.pdf 9.6 MB
002498/0000/m1/eu/13-pi/134-consultation/emea/emea-consultation-pil100penfill.pdf 1.3 MB
002498/0000/m1/eu/13-pi/134-consultation/emea/emea-consultation-pil100bridge.pdf 658 KB
002498/0000/m1/eu/13-pi/134-consultation/emea/emea-consultation-statement.pdf 123 KB
002498/0000/m1/eu/13-pi/136-braille/braille.pdf 65 KB
002498/0000/m1/eu/14-expert/141-quality/quality.pdf 1.2 MB
002498/0000/m1/eu/14-expert/142-nonclinical/nonclinical.pdf 817 KB
002498/0000/m1/eu/14-expert/143-clinical/clinical.pdf 1.8 MB
002498/0000/m1/eu/16-environrisk/161-nongmo/nongmo.pdf 216 KB
002498/0000/m1/eu/16-environrisk/161-nongmo/nongmo-johe.pdf 169 KB
002498/0000/m1/eu/18-pharmacovigilance/181-phvig-system/phvigsystem.pdf 1.9 MB
002498/0000/m1/eu/18-pharmacovigilance/182-riskmgt-system/riskmgtsystem.pdf 7.8 MB
002498/0000/m1/eu/19-clinical-trials/clinicaltrials.pdf 386 KB
002498/0000/m1/eu/110-paediatrics/paediatrics.pdf 430 KB
002498/0000/m1/eu/110-paediatrics/paediatrics-compliance.pdf 179 KB
002498/0000/m2/22-intro/introduction.pdf 67 KB
002498/0000/m2/23-qos/introduction.pdf 157 KB
002498/0000/m2/23-qos/drug-substance-geninfo.pdf 230 KB
002498/0000/m2/23-qos/drug-substance-manufacture.pdf 795 KB
002498/0000/m2/23-qos/drug-substance-characterization.pdf 807 KB
002498/0000/m2/23-qos/drug-substance-controlds.pdf 231 KB
002498/0000/m2/23-qos/drug-substance-refsta.pdf 113 KB
002498/0000/m2/23-qos/drug-substance-container.pdf 79 KB
002498/0000/m2/23-qos/drug-substance-stability.pdf 192 KB
002498/0000/m2/23-qos/drug-product-descrip.pdf 77 KB
002498/0000/m2/23-qos/drug-product-pharmdev.pdf 162 KB
002498/0000/m2/23-qos/drug-product-manufacture.pdf 134 KB
002498/0000/m2/23-qos/drug-product-control.pdf 75 KB
002498/0000/m2/23-qos/drug-product-controldp.pdf 304 KB
002498/0000/m2/23-qos/drug-product-refstand.pdf 60 KB
002498/0000/m2/23-qos/drug-product-container.pdf 1.1 MB
002498/0000/m2/23-qos/drug-product-stability100u.pdf 280 KB
002498/0000/m2/23-qos/appendices-facilequip.pdf 122 KB
002498/0000/m2/23-qos/appendices-adventitious.pdf 100 KB
002498/0000/m2/23-qos/regional-information.pdf 81 KB
002498/0000/m2/24-nonclin-over/nonclinical-overview-ideg.pdf 715 KB
002498/0000/m2/25-clin-over/clinical-overview-ideg.pdf 3.2 MB
002498/0000/m2/26-nonclin-sum/261-introduction-ideg.pdf 1.2 MB
002498/0000/m2/26-nonclin-sum/262-pharmacol-written-summary.pdf 394 KB
002498/0000/m2/26-nonclin-sum/263-pharmacol-tabulated-summary.pdf 277 KB
002498/0000/m2/26-nonclin-sum/264-pharmkin-written-summary.pdf 735 KB
002498/0000/m2/26-nonclin-sum/265-pharmkin-tabulated-summary.pdf 499 KB
002498/0000/m2/26-nonclin-sum/266-toxicology-written-summary.pdf 576 KB
002498/0000/m2/26-nonclin-sum/267-toxicology-tabulated-summary.pdf 440 KB
002498/0000/m2/27-clin-sum/271-summary-biopharm-ideg.pdf 514 KB
002498/0000/m2/27-clin-sum/272-summary-clin-pharm-ideg.pdf 3.6 MB
002498/0000/m2/27-clin-sum/273-summary-clin-efficacy-ideg.pdf 6.6 MB
002498/0000/m2/27-clin-sum/274-summary-clin-safety-ideg.pdf 2.3 MB
002498/0000/m2/27-clin-sum/275-literature-references.pdf 112 KB
002498/0000/m2/27-clin-sum/276-synopses-indiv-studies.pdf 187 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s1-gen-info/nomenclature.pdf 85 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s1-gen-info/structure.pdf 213 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s1-gen-info/general-properties.pdf 211 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manufacturer.pdf 73 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls.pdf 167 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-batchnumbering.pdf 225 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-fermentation.pdf 87 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-batchrecovery.pdf 137 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-batchpurification.pdf 126 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-propagation.pdf 163 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-recovery.pdf 152 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-purification.pdf 223 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-fillingstorage.pdf 191 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-useofcolumns.pdf 126 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-columrecovery.pdf 137 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-conditionsofuse.pdf 324 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-columnpurification.pdf 111 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-and-controls-reprocessing.pdf 93 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials.pdf 349 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-cellbanksystem.pdf 155 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-mastercellbank.pdf 174 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-yeastcellbank.pdf 159 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-strainidentification.pdf 312 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-workingcellbank.pdf 152 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-op13.pdf 138 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-protocol.pdf 113 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-lateextendedculture.pdf 141 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-manfproductioncells.pdf 142 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-geneticcharac.pdf 184 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-mediareagents.pdf 73 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-reagentsfermentation.pdf 74 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-rawmaterials.pdf 88 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-solutionsrecovery.pdf 100 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-rawmatrecovery.pdf 79 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-solventspurification.pdf 88 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-rawmatpurification.pdf 82 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-of-materials-biologicalorigin.pdf 71 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-inpro.pdf 109 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-analysis.pdf 72 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-southernblotanaly.pdf 115 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-phenotypedetermin.pdf 77 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-recovery.pdf 163 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-methodsofanalasis.pdf 61 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-analyticalhplc.pdf 68 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps.pdf 104 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-methodsinprocess.pdf 64 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-analytprocedure.pdf 102 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-valanalytproced.pdf 213 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-hplcmethodfortest.pdf 68 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-analytical7089.pdf 109 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-betweentestfacili.pdf 93 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-justificationrecovery.pdf 269 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-justificationpurificn.pdf 550 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-desb30k1.pdf 176 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-desb30k2.pdf 176 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-stabilitydatak1d2.pdf 110 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-comparison.pdf 122 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-stabilitydataka.pdf 131 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/control-critical-steps-stabilitydatafromprocess.pdf 126 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/process-validation.pdf 271 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/process-validation-impurities.pdf 296 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/process-validation-comparision.pdf 315 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/process-validation-fermentation.pdf 216 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/process-validation-purification.pdf 257 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-development.pdf 643 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-development-compaign.pdf 292 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-development-democomparability.pdf 1.2 MB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-development-processvalid.pdf 454 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s2-manuf/manuf-process-development-demodesb30.pdf 336 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s3-charac/elucidation-of-structure.pdf 890 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s3-charac/elucidation-of-structure-bioactivity.pdf 306 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s3-charac/impurities.pdf 700 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s3-charac/impurities-degaradationstudy.pdf 459 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s41-spec/specification.pdf 92 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s42-analyt-proc/analytical-procedure.pdf 67 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s42-analyt-proc/analytical-procedure-a7091a.pdf 139 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s42-analyt-proc/analytical-procedure-a7090.pdf 267 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s42-analyt-proc/analytical-procedure-a7092a.pdf 123 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s42-analyt-proc/analytical-procedure-b2003a.pdf 933 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s42-analyt-proc/analytical-procedure-a7093a.pdf 248 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s42-analyt-proc/analytical-procedure-fordrugsubstance.pdf 97 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s43-val-analyt-proc/validation-analyt-procedure.pdf 86 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s43-val-analyt-proc/validation-analyt-procedure-a7091a.pdf 318 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s43-val-analyt-proc/validation-analyt-procedure-a7090.pdf 414 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s43-val-analyt-proc/validation-analyt-procedure-a7092a.pdf 283 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s43-val-analyt-proc/validation-analyt-procedure-b2003a.pdf 214 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s43-val-analyt-proc/validation-analyt-procedure-a7093a.pdf 320 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s43-val-analyt-proc/validation-analyt-procedure-novomethods.pdf 82 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s43-val-analyt-proc/validation-analyt-procedure-b2003amethods.pdf 82 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s43-val-analyt-proc/validation-analyt-procedure-pharmacopoeia.pdf 80 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s44-batch-analys/batch-analyses.pdf 217 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s4-contr-drug-sub/32s45-justif-spec/justification-of-specification.pdf 220 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s5-ref-stand/reference-standards.pdf 244 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s5-ref-stand/reference-standards-estprotocol.pdf 108 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s5-ref-stand/reference-standards-secondaryrefrep.pdf 259 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s5-ref-stand/reference-standards-secondaryrefpro.pdf 100 KB
002498/0000/m3/32-body-data/32s-drug-sub/insulin-degludec-nnas/32s5-ref-stand/reference-standards-a5001a.pdf 98 KB
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