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Pfizer 16+ Documents
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File Name Date Produced File Size Link 125742_S112_M1_cover.pdf November 1, 2023 2 MB 125742_S111_M1_letter of authorization.pdf November 1, 2023 739 KB 125742_S111_M1_cover.pdf November 1, 2023 2 MB 125742_S111_M1_356h.pdf November 1, 2023 4 MB 125742_S80_M1_cover.pdf November 1, 2023 734 KB 125742_S63_M1_response 18aug2021.pdf November 1, 2023 2 MB 125742_S63_M1_cover.pdf November 1, 2023 2 MB 125742_S61_M1_response 17aug2021.pdf November 1, 2023 2 MB 125742_S61_M1_cover.pdf November 1, 2023 668 KB 125742_S60_M3_32s2_control critical steps manuf process.pdf November 1, 2023 2 MB STN 124742_Courtesy Copy_Pfizer BioNTech Comirnaty STN 125742 COVID 19 Vaccine Lot Notifications (2021).pdf November 1, 2023 200 KB FDA CBER 2021 5683 1150835 1200874_Slipsheet.pdf November 1, 2023 69 KB 125742 0_20219009.P0.pdf November 1, 2023 889 KB 125742 0_20219008.P0.pdf November 1, 2023 882 KB 125742 0_20219007.P0.pdf November 1, 2023 832 KB 125742 0_20219006.PC1.pdf November 1, 2023 902 KB 125742 0_20219006.P0.pdf November 1, 2023 902 KB 125742 0_20219005.P0.pdf November 1, 2023 898 KB 125742 0_20219004.P0.pdf November 1, 2023 903 KB 125742 0_20219003.PC1.pdf November 1, 2023 898 KB 125742 0_20219003.P0.pdf November 1, 2023 897 KB 125742 0_20219002.PC1.pdf November 1, 2023 905 KB 125742 0_20219002.P0.pdf November 1, 2023 905 KB 125742 0_20219001.PC1.pdf November 1, 2023 912 KB 125742 0_20219001.P0.pdf November 1, 2023 912 KB 125742_S116_M1_lab 1448 1 0.pdf November 1, 2023 1 MB 125742_S112_S2_M3_32s2_control critical steps manuf process.pdf November 1, 2023 2 MB 125742_S59_M1_response 17aug2021.pdf November 1, 2023 1 MB 125742_S59_M1_cover.pdf November 1, 2023 672 KB 125742_S57_M3_32p3_manufacturer diluent.pdf November 1, 2023 2 MB 125742_S57_M1_response 16aug2021.pdf November 1, 2023 2 MB 125742_S57_M1_cover.pdf November 1, 2023 2 MB 125742_S56_M1_response 13aug2021.pdf November 1, 2023 2 MB 125742_S56_M1_cover.pdf November 1, 2023 672 KB 125742_S55_M3_32p8_stability summary.pdf November 1, 2023 3 MB 125742_S55_M3_32p8_stability data long term.pdf November 1, 2023 3 MB 125742_S55_M2_introduction.pdf November 1, 2023 11 MB 125742_S55_M2_drug product stability.pdf November 1, 2023 3 MB 125742_S55_M2_32p8_stability data accelerated.pdf November 1, 2023 3 MB 125742_S55_M1_cover.pdf November 1, 2023 767 KB 125742_S53_M1_response 13aug2021.pdf November 1, 2023 1 MB 125742_S53_M1_cover.pdf November 1, 2023 675 KB 125742_S50_M3_32r_comirnaty lot release template.pdf November 1, 2023 2 MB 125742_S50_M1_response 13aug2021.pdf November 1, 2023 2 MB 125742_S50_M1_cover.pdf November 1, 2023 2 MB 125742_S48_M1_response 06aug2021.pdf November 1, 2023 2 MB 125742_S60_M1_response 17aug2021.pdf November 1, 2023 2 MB 125742_S60_M1_cover.pdf November 1, 2023 2 MB 125742_S47_M1_response 11aug2021.pdf November 1, 2023 2 MB 125742_S47_M1_cover.pdf November 1, 2023 2 MB 125742_S44_M1_response 10aug2021.pdf November 1, 2023 2 MB 125742_S44_M1_cover.pdf November 1, 2023 2 MB 125742_S43_M3_32p3_manufacturers.pdf November 1, 2023 2 MB 125742_S43_M1_response 05aug2021.pdf November 1, 2023 2 MB 125742_S43_M1_cover.pdf November 1, 2023 2 MB 125742_S42_M3_32r_comirnaty lot release template.pdf November 1, 2023 709 KB 125742_S42_M1_response 04aug2021.pdf November 1, 2023 4 MB 125742_S42_M1_cover.pdf November 1, 2023 2 MB 125742_S40_M1_response 06aug2021.pdf November 1, 2023 2 MB 125742_S40_M1_cover.pdf November 1, 2023 2 MB 125742_S37_M1_response 05aug2021.pdf November 1, 2023 2 MB 125742_S37_M1_cover.pdf November 1, 2023 2 MB 125742_S36_M1_response 02aug2021.pdf November 1, 2023 2 MB 125742_S36_M1_cover.pdf November 1, 2023 2 MB 125742_S35_M1_response 04aug2021.pdf November 1, 2023 1 MB 125742_S35_M1_cover.pdf November 1, 2023 2 MB 125742_S48_M1_cover.pdf November 1, 2023 2 MB 125742_S47_M3_32p3_manufacturer diluent.pdf November 1, 2023 2 MB 125742_S34_M1_response 03aug2021.pdf November 1, 2023 1 MB 125742_S34_M1_cover.pdf November 1, 2023 668 KB 125742_S30_M1_response 26jul2021.pdf November 1, 2023 1 MB 125742_S30_M1_cover.pdf November 1, 2023 671 KB 125742_S26_M1_fda bnt cl.pdf November 1, 2023 996 KB 125742_S26_M1_cover.pdf November 1, 2023 718 KB 125742_S26_M1_andover 483 response.pdf November 1, 2023 1 MB 125742_S25_M1_response 26jul2021.pdf November 1, 2023 1 MB 125742_S25_M1_cover.pdf November 1, 2023 668 KB 125742_S22_M1_response 16jul2021.pdf November 1, 2023 1 MB 125742_S22_M1_cover.pdf November 1, 2023 678 KB 125742_S19_M1_response 02jul2021.pdf November 1, 2023 2 MB 125742_S19_M1_cover.pdf November 1, 2023 2 MB 125742_S17_M1_reponse 09jul2021.pdf November 1, 2023 2 MB 125742_S17_M1_cover.pdf November 1, 2023 674 KB 125742_S15_M3_32r_comirnaty lot release 16jul2021.pdf November 1, 2023 1 MB 125742_S15_M1_response 16jul2021 lrp samples.pdf November 1, 2023 1 MB 125742_S34_M3_32a3_excipient information nomenclature alc 0315.pdf November 1, 2023 2 MB 125742_S11_M3_32r_fd0809 coa.pdf November 1, 2023 836 KB 125742_S11_M3_32r_fc3184 coa.pdf November 1, 2023 836 KB 125742_S11_M3_32r_fc3181 coa.pdf November 1, 2023 840 KB 125742_S11_M3_32r_677365 1g a 010 coa.pdf November 1, 2023 636 KB 125742_S11_M3_32r_677315o 1g a 010 coa.pdf November 1, 2023 635 KB 125742_S11_M3_32r_677159p 1g a 010 coa.pdf November 1, 2023 636 KB 125742_S11_M3_32r_677100p 1g a 010 coa.pdf November 1, 2023 636 KB 125742_S11_M3_32r_21y513c2501 coa.pdf November 1, 2023 636 KB 125742_S11_M3_32r_21y513c2401 coa.pdf November 1, 2023 1 MB 125742_S11_M3_32r_21y513c2301 coa.pdf November 1, 2023 1 MB 125742_S11_M1_response 25jun2021 cmc.pdf November 1, 2023 2 MB 125742_S11_M1_cover.pdf November 1, 2023 2 MB 125742_S5_M1_response 20 may 2021 facilities.pdf November 1, 2023 1 MB 125742_S5_M1_cover.pdf November 1, 2023 725 KB 125742_S15_M1_cover.pdf November 1, 2023 675 KB 125742_S11_M3_32r_pf 07302048 dp rm coa.pdf November 1, 2023 634 KB 125742_S2_M3_32s4_analytical procedure overview.pdf November 1, 2023 2 MB 125742_S2_M3_32s2_manufacturer.pdf November 1, 2023 2 MB 125742_S2_M3_32s2_control critical steps manuf process.pdf November 1, 2023 2 MB 125742_S2_M3_32r_reg info manufacturing schedules.pdf November 1, 2023 2 MB 125742_S2_M3_32r_reg info lot release documentation package.pdf November 1, 2023 4 MB 125742_S2_M3_32p53_validation analytical procedures overview.pdf November 1, 2023 2 MB 125742_S2_M3_32p53_validation analytical procedure rt pcr.pdf November 1, 2023 2 MB 125742_S2_M3_32p53_validation analytical procedure cap gel electro.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure subvis particulate matter.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure rt pcr.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure overview.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure osmometry.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure endotoxin.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure cap gel electro.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_stability summary.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_stability data thermal stress cycling.pdf November 1, 2023 3 MB 125742_S2_M3_32p8_stability data photostability.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_stability data long term.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_stability data accelerated.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_postapproval stability.pdf November 1, 2023 2 MB 125742_S2_M3_32p5_specifications.pdf November 1, 2023 2 MB 125742_S2_M3_32p5_batch analyses.pdf November 1, 2023 3 MB 125742_S2_M3_32p4_novel excipients.pdf November 1, 2023 2 MB 125742_S2_M3_32p4_excipients human animal.pdf November 1, 2023 2 MB 125742_S2_M3_32p3_manufacturers.pdf November 1, 2023 2 MB 125742_S2_M3_32s4_validation analyt procedure overview.pdf November 1, 2023 2 MB 125742_S2_M3_32s4_specification.pdf November 1, 2023 2 MB 125742_S2_M3_32p3_control critical steps in process mon control overview.pdf November 1, 2023 2 MB 125742_S2_M3_32p2_pharmaceutical development introduction.pdf November 1, 2023 2 MB 125742_S2_M3_32p1_description and composition.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information structure alc 0315.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information structure alc 0159.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information nomenclature alc 0315.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information nomenclature alc 0159.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information excipients alc 0315.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information excipients alc 0159.pdf November 1, 2023 2 MB 125742_S2_M3_32a2_adventitious agents puurs.pdf November 1, 2023 2 MB 125742_S2_M3_32a2_adventitious agents kalamazoo.pdf November 1, 2023 2 MB 125742_S2_M3_32a2_adventitious agents andover.pdf November 1, 2023 2 MB 125742_S2_M2_introduction.pdf November 1, 2023 2 MB 125742_S2_M2_drug product stability.pdf November 1, 2023 2 MB 125742_S2_M2_drug product reference stand or materials.pdf November 1, 2023 2 MB 125742_S2_M2_drug product description composition drug prod.pdf November 1, 2023 2 MB 125742_S2_M2_appendices adv agen safe val.pdf November 1, 2023 2 MB 125742_S1_M1_financial cert summary.pdf November 1, 2023 715 KB 125742_S1_M1_financial cert 3455.pdf November 1, 2023 2 MB 125742_S1_M1_1.9.4_ipsp agreed.pdf November 1, 2023 2 MB 125742_S1_M1_1.9.2_ped studies deferral req.pdf November 1, 2023 11 MB 138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdf November 1, 2023 1 MB 137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdf November 1, 2023 813 KB 136_BLA_125742_RNAcontent_InSupportTesting.pdf November 1, 2023 739 KB 135_Courtesy Copy_BLA 125742 0_November 8, 2021_Summary Basis for Regulatory Action COMIRNATY.pdf November 1, 2023 540 KB 134_Courtesy Copy_BLA 125742 0_Toxicology Review COMIRNATY.pdf November 1, 2023 4 MB 133_Courtesy Copy_BLA 125742 0_Benefit Risk Assessment Review Memo COMIRNATY.pdf November 1, 2023 3 MB 132_BLA 125742 0_09 13 2021_Memo_Committee Memo_Review (1).pdf November 1, 2023 1 MB 131_Courtesy Copy_BLA 125742 0_Clinical Review Memo, August 23, 2021 COMIRNATY.pdf November 1, 2023 1 MB 125742_S2_M3_32p3_batch formula.pdf November 1, 2023 2 MB 127_Courtesy Copy_BLA 125742 0_CBER Sentinel Program Sufficiency Memo COMIRNATY.pdf November 1, 2023 164 KB 125_BLA 125742 0_08 23 2021_Memo_Committee Memo_Toxico.pdf November 1, 2023 4 MB 124_BLA 125742 0_08 23 2021_Memo_Committee Memo_SBRA.pdf November 1, 2023 1 MB 123_Courtesy Copy_BLA 125742 0_August 23, 2021 Approval Letter Comirnaty.pdf November 1, 2023 157 KB 122_BLA 125742 0_08 22 2021_Telecon_Labeling via FAX_e.pdf November 1, 2023 775 KB 121_Courtesy Copy_BLA 125742 0_Employee Officer List Memo, August 22, 2021 COMIRNATY.pdf November 1, 2023 25 KB 120_Courtesy Copy_BLA 125742 0_CBER CMC BLA Review Memo COMIRNATY.pdf November 1, 2023 1 MB 119_Courtesy Copy_BLA 125742 0_Real World Evidence BLA Memo COMIRNATY.pdf November 1, 2023 63 KB 118_1_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdf November 1, 2023 659 KB 117_2_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdf November 1, 2023 1 MB 116_BLA 125742 0_08 21 2021_Inspection Related_Establi.pdf November 1, 2023 2 MB 115_1_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdf November 1, 2023 789 KB 111_BLA 125742 0_08 21 2021_Telecon_Advice.pdf November 1, 2023 660 KB 110_1_Courtesy Copy_BLA 125742 0_Analytical Method Review Memo COMIRNATY.pdf November 1, 2023 308 KB 109_Courtesy Copy_2_BLA 125742 0_CMC Review Memo, August 21, 2021 COMIRNATY.pdf November 1, 2023 839 KB 108_BLA 125742 0_08 21 2021_Inspection Related_Inspect.pdf November 1, 2023 1 MB 107A_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf November 1, 2023 815 KB 107_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf November 1, 2023 806 KB 105_BLA 125742 0_08 20 2021_Telecon_Advice_Information.pdf November 1, 2023 761 KB 103_2_BLA 125742 0_08 20 2021_Memo_Test Results.pdf November 1, 2023 1 MB 102_1_BLA 125742 0_08 20 2021_Memo_Test Results.pdf November 1, 2023 1 MB 101_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Addendum Memo COMIRNATY.pdf November 1, 2023 145 KB 100A_BLA 125742 0_08 20 2021_Memo_Other.pdf November 1, 2023 1 MB 100_BLA 125742 0_08 20 2021_Memo_Other.pdf November 1, 2023 1 MB 99_BLA 125742 0_08 20 2021_Memo_Committee Memo_Labeli.pdf November 1, 2023 2 MB 95_BLA 125742 0_08 19 2021_Memo_Compliance Check Acce.pdf November 1, 2023 2 MB 94_Courtesy Copy_1_BLA 125742 0_Statistical Review COMIRNATY.pdf November 1, 2023 261 KB 93_Courtesy Copy_2_BLA 125742 0_Statistical Review COMIRNATY.pdf November 1, 2023 301 KB 92_BLA 125742 0_08 19 2021_Inspection Related_Inspect.pdf November 1, 2023 2 MB 89_1_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf November 1, 2023 743 KB 87_3_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf November 1, 2023 1 MB 129_BLA 125742 0_08 30 2021_Telecon_Other.pdf November 1, 2023 638 KB 128_BLA 125742 0_08 30 2021_Telecon_Other (1).pdf November 1, 2023 637 KB 49_BLA 125742 0_08 06 2021_Letter_UNII Code Notificat.pdf November 1, 2023 766 KB 47_1_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdf November 1, 2023 755 KB 46_2_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdf November 1, 2023 789 KB 45_BLA 125742 0_08 05 2021_Telecon_Advice.pdf November 1, 2023 801 KB 44_3_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf November 1, 2023 767 KB 43A_STN 125742.0 4AUG21 LRP FU IR 2.pdf November 1, 2023 2 MB 42_1_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf November 1, 2023 773 KB 40_2_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdf November 1, 2023 772 KB 39_2_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdf November 1, 2023 784 KB 33_1_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdf November 1, 2023 734 KB 32_1_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdf November 1, 2023 890 KB 27_BLA 125742 0_07 19 2021_Telecon_Advice.pdf November 1, 2023 746 KB 26_2_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdf November 1, 2023 789 KB 25_1_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdf November 1, 2023 794 KB 21_BLA 125742 0_07 15 2021_Letter_Filing Notification.pdf November 1, 2023 722 KB 18_BLA 125742 0_07 09 2021_Telecon_Information Reques.pdf November 1, 2023 765 KB 15_BLA 125742 0_07 02 2021_Telecon_Information Reques.pdf November 1, 2023 819 KB 10_BLA 125742 11_12 22 2021_Memo_Committee Memo_CMC.pdf November 1, 2023 757 KB 9_IND_19736_491_29 Sep 2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdf November 1, 2023 716 KB 8_IND_19736_453_26 Aug 2021_DEBORAH_DEBORAH__RO_.pdf November 1, 2023 717 KB 8_1_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdf November 1, 2023 1 MB 7_IND_19736_409_26 Jul 2021_DEBORAH_DEBORAH__RO_.pdf November 1, 2023 718 KB 6_IND_19736_366_24 Jun 2021_DEBORAH_DEBORAH__RO_.pdf November 1, 2023 717 KB 5_IND_19736_335_19 May 2021_DEBORAH_DEBORAH__RC_.pdf November 1, 2023 716 KB 4_IND_19736_289_27 Apr 2021_DEBORAH_DEBORAH__RC_.pdf November 1, 2023 717 KB 3_IND_19736_243_19 Mar 2021_KERRY_KERRY__RO_.pdf November 1, 2023 696 KB 3_BLA 125742 0_05 20 2021_Telecon_Information Reques.pdf November 1, 2023 747 KB 2_IND_19736_214_03 Mar 2021_KERRY_KERRY__RO_.pdf November 1, 2023 698 KB 1_IND_19736_185_23 Feb 2021_KERRY_KERRY__RO_.pdf November 1, 2023 697 KB 1_BLA 125742 0_05 13 2021_Letter_Acknowledgement Let.pdf November 1, 2023 713 KB 86_BLA 125742 0_08 18 2021_Telecon_Advice.pdf November 1, 2023 984 KB 85_Courtesy Copy_BLA 125742 0_Statistical Review COMIRNATY.pdf November 1, 2023 127 KB 84_BLA 125742 0_08 18 2021_Memo_Committee Memo_Review.pdf November 1, 2023 706 KB 83_BLA 125742 0_08 17 2021_Telecon_Other.pdf November 1, 2023 770 KB 81_1_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf November 1, 2023 760 KB 79_3_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf November 1, 2023 753 KB 75_1_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf November 1, 2023 717 KB 74_3_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf November 1, 2023 746 KB 73_2_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf November 1, 2023 1 MB 68B_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf November 1, 2023 690 KB 68A_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf November 1, 2023 710 KB 68_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf November 1, 2023 753 KB 66_4_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf November 1, 2023 794 KB 65_BLA 125742 0_08 13 2021_Memo_Request For Complianc.pdf November 1, 2023 864 KB 64_Courtesy Copy_BLA 125742 0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 COMIRNATY.pdf November 1, 2023 81 KB 62_BLA 125742 0_08 12 2021_Memo_Committee Memo_Requir.pdf November 1, 2023 1 MB 61_BLA 125742 0_08 11 2021_Telecon_Other.pdf November 1, 2023 719 KB 60_BLA 125742 0_08 11 2021_Telecon_Information Reques.pdf November 1, 2023 764 KB 58_2_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdf November 1, 2023 755 KB 55_BLA 125742 0_08 09 2021_Telecon_Advice.pdf November 1, 2023 2 MB 54_BLA 125742 0_08 09 2021_Inspection Related_Inspect.pdf November 1, 2023 1 MB 53_2_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdf November 1, 2023 765 KB 52_1_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdf November 1, 2023 1 MB 51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdf November 1, 2023 279 KB 19736_S0214_M1_cover.pdf October 1, 2023 716 KB 3_PM_S89_BLA 125742 5_09 21 2021_Telecon_Other.pdf October 1, 2023 724 KB 019736_S387_M5_c4591008 interim protocol deviations.pdf October 1, 2023 633 KB 125742_S5_M3_requirements travel belgium.pdf October 1, 2023 635 KB 125742_S5_M3_guidelines travel red zone belgium.pdf October 1, 2023 643 KB 019736_S70_M5_vr mqr 10211 10212 dlq.pdf October 1, 2023 663 KB 019736_S387_M5_c4591012 interim sponsor signature.pdf October 1, 2023 664 KB 019736_S157_M1_cover.pdf October 1, 2023 668 KB 019736_S387_M5_c4591008 interim excluded subjects.pdf October 1, 2023 684 KB 19736_S0289_M1_cover.pdf October 1, 2023 687 KB 19736_S0185_M1_cover.pdf October 1, 2023 687 KB 019736_S70_M1_cover.pdf October 1, 2023 689 KB 19736_S0369_M1_cover.pdf October 1, 2023 704 KB 019736_S70_M5_vr mqr 10211 10212 pq.pdf October 1, 2023 708 KB 19736_S0335_M1_cover.pdf October 1, 2023 735 KB 19736_S0408_M1_cover.pdf October 1, 2023 736 KB 19736_S0366_M1_cover.pdf October 1, 2023 736 KB 19736_S0453_M1_cover.pdf October 1, 2023 739 KB 125742_2_BLA 125742 0_05 18 2021_Telecon_Information Reques.pdf October 1, 2023 742 KB 19736_S0491_M1_cover.pdf October 1, 2023 742 KB 125742_S2_M5_5.4_who 2005.pdf October 1, 2023 747 KB 125742_S2_M5_5.4_who 2019.pdf October 1, 2023 747 KB 019736_S414_M1_cover.pdf October 1, 2023 753 KB 019736_S222_M1_cover.pdf October 1, 2023 754 KB 019736_S488_M1_cover.pdf October 1, 2023 756 KB 019736_S196_M1_cover.pdf October 1, 2023 759 KB 019736_S444_M5_c4591007 p2 3 older child assent lower dose eval.pdf October 1, 2023 773 KB 5_PM_S102_1_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdf October 1, 2023 782 KB 6_PM_S102_2_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdf October 1, 2023 783 KB 019736_S444_M5_c4591007 p1 older children assent lower dose eval icd.pdf October 1, 2023 786 KB 19736_S0243_M1_cover.pdf October 1, 2023 733 KB 019736_S387_M5_c4591008 interim sponsor signature.pdf October 1, 2023 824 KB 19736_S0185_M1_1571.pdf October 1, 2023 827 KB 7_PM_S102_BLA 125742 8_09 29 2021_Letter_Waiver Request.pdf October 1, 2023 830 KB 11_PM_S136_BLA 125742 31_10 30 2021_Memo_Final Review Memo.pdf October 1, 2023 835 KB 019736_S488_M5_c4591007 p2 3 older children assent troponin icd.pdf October 1, 2023 837 KB 019736_S222_M5_c4591020 informed consent form.pdf October 1, 2023 867 KB 019736_S488_M5_c4591007 p2 3 parent icd pbo controlled selected dose.pdf October 1, 2023 880 KB 9_PM_S105_BLA 125742 9_09 20 2021_Telecon_Advice.pdf October 1, 2023 941 KB 019736_S444_M5_c4591007 p2 3 adult participant icd lower dose eval.pdf October 1, 2023 966 KB 019736_S444_M5_c4591007 p1 adult participant icd lower dose eval.pdf October 1, 2023 974 KB 4_PM_S89_BLA 125742 5_09 22 2021_Telecon_Advice.pdf October 1, 2023 983 KB 019736_S444_M5_c4591007 p2 3 parent icd lower dose eval.pdf October 1, 2023 988 KB 019736_S444_M5_c4591007 p1 parent icd lower dose eval.pdf October 1, 2023 995 KB 019736_S470_M1_cover.pdf October 1, 2023 795 KB 125742_S2_M1_356h.pdf October 1, 2023 813 KB 1_PM_S85_BLA 125742 4_09 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