| 125742 0_20219001.P0.pdf | November 1, 2023 | 912 KB | |
| 125742_S112_S2_M3_32s2_control critical steps manuf process.pdf | November 1, 2023 | 2 MB | |
| 125742_S116_M1_lab 1448 1 0.pdf | November 1, 2023 | 1 MB | |
| 125742_S112_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S111_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S111_M1_letter of authorization.pdf | November 1, 2023 | 739 KB | |
| 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_S61_M1_response 17aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S63_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S60_M3_32s2_control critical steps manuf process.pdf | November 1, 2023 | 2 MB | |
| 125742_S61_M1_cover.pdf | November 1, 2023 | 668 KB | |
| 125742_S60_M1_response 17aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S59_M1_response 17aug2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S60_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S57_M3_32p3_manufacturer diluent.pdf | November 1, 2023 | 2 MB | |
| 125742_S59_M1_cover.pdf | November 1, 2023 | 672 KB | |
| 125742_S57_M1_response 16aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742 0_20219009.P0.pdf | November 1, 2023 | 889 KB | |
| FDA CBER 2021 5683 1150835 1200874_Slipsheet.pdf | November 1, 2023 | 69 KB | |
| STN 124742_Courtesy Copy_Pfizer BioNTech Comirnaty STN 125742 COVID 19 Vaccine Lot Notifications (2021).pdf | November 1, 2023 | 200 KB | |
| 125742 0_20219007.P0.pdf | November 1, 2023 | 832 KB | |
| 125742 0_20219008.P0.pdf | November 1, 2023 | 882 KB | |
| 125742 0_20219006.P0.pdf | November 1, 2023 | 902 KB | |
| 125742 0_20219006.PC1.pdf | November 1, 2023 | 902 KB | |
| 125742 0_20219004.P0.pdf | November 1, 2023 | 903 KB | |
| 125742 0_20219005.P0.pdf | November 1, 2023 | 898 KB | |
| 125742 0_20219003.P0.pdf | November 1, 2023 | 897 KB | |
| 125742 0_20219003.PC1.pdf | November 1, 2023 | 898 KB | |
| 125742 0_20219002.P0.pdf | November 1, 2023 | 905 KB | |
| 125742 0_20219002.PC1.pdf | November 1, 2023 | 905 KB | |
| 125742 0_20219001.PC1.pdf | November 1, 2023 | 912 KB | |
| 125742_S56_M1_response 13aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S55_M3_32p8_stability summary.pdf | November 1, 2023 | 3 MB | |
| 125742_S56_M1_cover.pdf | November 1, 2023 | 672 KB | |
| 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_S53_M1_response 13aug2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S55_M1_cover.pdf | November 1, 2023 | 767 KB | |
| 125742_S50_M3_32r_comirnaty lot release template.pdf | November 1, 2023 | 2 MB | |
| 125742_S53_M1_cover.pdf | November 1, 2023 | 675 KB | |
| 125742_S50_M1_response 13aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S48_M1_response 06aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S50_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S48_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S47_M1_response 11aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S47_M3_32p3_manufacturer diluent.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_S43_M3_32p3_manufacturers.pdf | November 1, 2023 | 2 MB | |
| 125742_S44_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S43_M1_response 05aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S42_M3_32r_comirnaty lot release template.pdf | November 1, 2023 | 709 KB | |
| 125742_S43_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S42_M1_response 04aug2021.pdf | November 1, 2023 | 4 MB | |
| 125742_S40_M1_response 06aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S42_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S40_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S37_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S37_M1_response 05aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S36_M1_response 02aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S35_M1_response 04aug2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S36_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S35_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S34_M1_response 03aug2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S34_M3_32a3_excipient information nomenclature alc 0315.pdf | November 1, 2023 | 2 MB | |
| 125742_S57_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S26_M1_fda bnt cl.pdf | November 1, 2023 | 996 KB | |
| 125742_S30_M1_cover.pdf | November 1, 2023 | 671 KB | |
| 125742_S26_M1_andover 483 response.pdf | November 1, 2023 | 1 MB | |
| 125742_S26_M1_cover.pdf | November 1, 2023 | 718 KB | |
| 125742_S25_M1_response 26jul2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S22_M1_response 16jul2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S25_M1_cover.pdf | November 1, 2023 | 668 KB | |
| 125742_S19_M1_response 02jul2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S22_M1_cover.pdf | November 1, 2023 | 678 KB | |
| 125742_S19_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S17_M1_cover.pdf | November 1, 2023 | 674 KB | |
| 125742_S17_M1_reponse 09jul2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S15_M1_response 16jul2021 lrp samples.pdf | November 1, 2023 | 1 MB | |
| 125742_S15_M3_32r_comirnaty lot release 16jul2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S11_M3_32r_pf 07302048 dp rm coa.pdf | November 1, 2023 | 634 KB | |
| 125742_S15_M1_cover.pdf | November 1, 2023 | 675 KB | |
| 125742_S11_M3_32r_fc3184 coa.pdf | November 1, 2023 | 836 KB | |
| 125742_S11_M3_32r_fd0809 coa.pdf | November 1, 2023 | 836 KB | |
| 125742_S11_M3_32r_677365 1g a 010 coa.pdf | November 1, 2023 | 636 KB | |
| 125742_S11_M3_32r_fc3181 coa.pdf | November 1, 2023 | 840 KB | |
| 125742_S11_M3_32r_677100p 1g a 010 coa.pdf | November 1, 2023 | 636 KB | |
| 125742_S11_M3_32r_677159p 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_21y513c2401 coa.pdf | November 1, 2023 | 1 MB | |
| 125742_S11_M3_32r_21y513c2501 coa.pdf | November 1, 2023 | 636 KB | |
| 125742_S11_M1_response 25jun2021 cmc.pdf | November 1, 2023 | 2 MB | |
| 125742_S11_M3_32r_21y513c2301 coa.pdf | November 1, 2023 | 1 MB | |
| 125742_S11_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S5_M1_cover.pdf | November 1, 2023 | 725 KB | |
| 125742_S5_M1_response 20 may 2021 facilities.pdf | November 1, 2023 | 1 MB | |
| 125742_S2_M3_32s4_specification.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32s4_validation analyt procedure overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32s4_analytical procedure overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S30_M1_response 26jul2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S34_M1_cover.pdf | November 1, 2023 | 668 KB | |
| 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 procedure rt pcr.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p53_validation analytical procedures overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p52_analytical procedure subvis particulate matter.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 rt pcr.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 overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p52_analytical procedure endotoxin.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p8_stability summary.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 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_batch analyses.pdf | November 1, 2023 | 3 MB | |
| 125742_S2_M3_32p5_specifications.pdf | November 1, 2023 | 2 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_control critical steps in process mon control overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p3_manufacturers.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p3_batch formula.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p1_description and composition.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p2_pharmaceutical development introduction.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 structure alc 0315.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 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_32a2_adventitious agents kalamazoo.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 andover.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_drug product stability.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_introduction.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_drug product reference stand or materials.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_appendices adv agen safe val.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_drug product description composition drug prod.pdf | November 1, 2023 | 2 MB | |
| 125742_S1_M1_financial cert 3455.pdf | November 1, 2023 | 2 MB | |
| 125742_S1_M1_financial cert summary.pdf | November 1, 2023 | 715 KB | |
| 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 | |
| 125742_S2_M3_32s2_control critical steps manuf process.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32s2_manufacturer.pdf | November 1, 2023 | 2 MB | |
| 133_Courtesy Copy_BLA 125742 0_Benefit Risk Assessment Review Memo COMIRNATY.pdf | November 1, 2023 | 3 MB | |
| 131_Courtesy Copy_BLA 125742 0_Clinical Review Memo, August 23, 2021 COMIRNATY.pdf | November 1, 2023 | 1 MB | |
| 132_BLA 125742 0_09 13 2021_Memo_Committee Memo_Review (1).pdf | November 1, 2023 | 1 MB | |
| 127_Courtesy Copy_BLA 125742 0_CBER Sentinel Program Sufficiency Memo COMIRNATY.pdf | November 1, 2023 | 164 KB | |
| 128_BLA 125742 0_08 30 2021_Telecon_Other (1).pdf | November 1, 2023 | 637 KB | |
| 129_BLA 125742 0_08 30 2021_Telecon_Other.pdf | November 1, 2023 | 638 KB | |
| 125_BLA 125742 0_08 23 2021_Memo_Committee Memo_Toxico.pdf | November 1, 2023 | 4 MB | |
| 123_Courtesy Copy_BLA 125742 0_August 23, 2021 Approval Letter Comirnaty.pdf | November 1, 2023 | 157 KB | |
| 124_BLA 125742 0_08 23 2021_Memo_Committee Memo_SBRA.pdf | November 1, 2023 | 1 MB | |
| 120_Courtesy Copy_BLA 125742 0_CBER CMC BLA Review Memo COMIRNATY.pdf | November 1, 2023 | 1 MB | |
| 121_Courtesy Copy_BLA 125742 0_Employee Officer List Memo, August 22, 2021 COMIRNATY.pdf | November 1, 2023 | 25 KB | |
| 122_BLA 125742 0_08 22 2021_Telecon_Labeling via FAX_e.pdf | November 1, 2023 | 775 KB | |
| 118_1_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 659 KB | |
| 119_Courtesy Copy_BLA 125742 0_Real World Evidence BLA Memo COMIRNATY.pdf | November 1, 2023 | 63 KB | |
| 116_BLA 125742 0_08 21 2021_Inspection Related_Establi.pdf | November 1, 2023 | 2 MB | |
| 117_2_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 1 MB | |
| 111_BLA 125742 0_08 21 2021_Telecon_Advice.pdf | November 1, 2023 | 660 KB | |
| 115_1_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdf | November 1, 2023 | 789 KB | |
| 136_BLA_125742_RNAcontent_InSupportTesting.pdf | November 1, 2023 | 739 KB | |
| 109_Courtesy Copy_2_BLA 125742 0_CMC Review Memo, August 21, 2021 COMIRNATY.pdf | November 1, 2023 | 839 KB | |
| 110_1_Courtesy Copy_BLA 125742 0_Analytical Method Review Memo COMIRNATY.pdf | November 1, 2023 | 308 KB | |
| 134_Courtesy Copy_BLA 125742 0_Toxicology Review COMIRNATY.pdf | November 1, 2023 | 4 MB | |
| 135_Courtesy Copy_BLA 125742 0_November 8, 2021_Summary Basis for Regulatory Action COMIRNATY.pdf | November 1, 2023 | 540 KB | |
| 107_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf | November 1, 2023 | 806 KB | |
| 103_2_BLA 125742 0_08 20 2021_Memo_Test Results.pdf | November 1, 2023 | 1 MB | |
| 105_BLA 125742 0_08 20 2021_Telecon_Advice_Information.pdf | November 1, 2023 | 761 KB | |
| 101_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Addendum Memo COMIRNATY.pdf | November 1, 2023 | 145 KB | |
| 102_1_BLA 125742 0_08 20 2021_Memo_Test Results.pdf | November 1, 2023 | 1 MB | |
| 100_BLA 125742 0_08 20 2021_Memo_Other.pdf | November 1, 2023 | 1 MB | |
| 100A_BLA 125742 0_08 20 2021_Memo_Other.pdf | November 1, 2023 | 1 MB | |
| 95_BLA 125742 0_08 19 2021_Memo_Compliance Check Acce.pdf | November 1, 2023 | 2 MB | |
| 99_BLA 125742 0_08 20 2021_Memo_Committee Memo_Labeli.pdf | November 1, 2023 | 2 MB | |
| 93_Courtesy Copy_2_BLA 125742 0_Statistical Review COMIRNATY.pdf | November 1, 2023 | 301 KB | |
| 94_Courtesy Copy_1_BLA 125742 0_Statistical Review COMIRNATY.pdf | November 1, 2023 | 261 KB | |
| 89_1_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf | November 1, 2023 | 743 KB | |
| 92_BLA 125742 0_08 19 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 2 MB | |
| 86_BLA 125742 0_08 18 2021_Telecon_Advice.pdf | November 1, 2023 | 984 KB | |
| 87_3_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf | November 1, 2023 | 1 MB | |
| 84_BLA 125742 0_08 18 2021_Memo_Committee Memo_Review.pdf | November 1, 2023 | 706 KB | |
| 85_Courtesy Copy_BLA 125742 0_Statistical Review COMIRNATY.pdf | November 1, 2023 | 127 KB | |
| 79_3_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf | November 1, 2023 | 753 KB | |
| 81_1_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf | November 1, 2023 | 760 KB | |
| 83_BLA 125742 0_08 17 2021_Telecon_Other.pdf | November 1, 2023 | 770 KB | |
| 74_3_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 746 KB | |
| 75_1_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 717 KB | |
| 68B_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | November 1, 2023 | 690 KB | |
| 73_2_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 1 MB | |
| 68_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | November 1, 2023 | 753 KB | |
| 68A_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | November 1, 2023 | 710 KB | |
| 65_BLA 125742 0_08 13 2021_Memo_Request For Complianc.pdf | November 1, 2023 | 864 KB | |
| 66_4_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | November 1, 2023 | 794 KB | |
| 62_BLA 125742 0_08 12 2021_Memo_Committee Memo_Requir.pdf | November 1, 2023 | 1 MB | |
| 64_Courtesy Copy_BLA 125742 0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 COMIRNATY.pdf | November 1, 2023 | 81 KB | |
| 107A_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf | November 1, 2023 | 815 KB | |
| 108_BLA 125742 0_08 21 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 1 MB | |
| 47_1_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdf | November 1, 2023 | 755 KB | |
| 45_BLA 125742 0_08 05 2021_Telecon_Advice.pdf | November 1, 2023 | 801 KB | |
| 46_2_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdf | November 1, 2023 | 789 KB | |
| 43A_STN 125742.0 4AUG21 LRP FU IR 2.pdf | November 1, 2023 | 2 MB | |
| 44_3_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf | November 1, 2023 | 767 KB | |
| 40_2_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdf | November 1, 2023 | 772 KB | |
| 42_1_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf | November 1, 2023 | 773 KB | |
| 33_1_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdf | November 1, 2023 | 734 KB | |
| 39_2_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdf | November 1, 2023 | 784 KB | |
| 27_BLA 125742 0_07 19 2021_Telecon_Advice.pdf | November 1, 2023 | 746 KB | |
| 32_1_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdf | November 1, 2023 | 890 KB | |
| 25_1_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 794 KB | |
| 26_2_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 789 KB | |
| 15_BLA 125742 0_07 02 2021_Telecon_Information Reques.pdf | November 1, 2023 | 819 KB | |
| 18_BLA 125742 0_07 09 2021_Telecon_Information Reques.pdf | November 1, 2023 | 765 KB | |
| 21_BLA 125742 0_07 15 2021_Letter_Filing Notification.pdf | November 1, 2023 | 722 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 | |
| 10_BLA 125742 11_12 22 2021_Memo_Committee Memo_CMC.pdf | November 1, 2023 | 757 KB | |
| 8_1_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdf | November 1, 2023 | 1 MB | |
| 8_IND_19736_453_26 Aug 2021_DEBORAH_DEBORAH__RO_.pdf | November 1, 2023 | 717 KB | |
| 6_IND_19736_366_24 Jun 2021_DEBORAH_DEBORAH__RO_.pdf | November 1, 2023 | 717 KB | |
| 7_IND_19736_409_26 Jul 2021_DEBORAH_DEBORAH__RO_.pdf | November 1, 2023 | 718 KB | |
| 4_IND_19736_289_27 Apr 2021_DEBORAH_DEBORAH__RC_.pdf | November 1, 2023 | 717 KB | |
| 5_IND_19736_335_19 May 2021_DEBORAH_DEBORAH__RC_.pdf | November 1, 2023 | 716 KB | |
| 2_IND_19736_214_03 Mar 2021_KERRY_KERRY__RO_.pdf | November 1, 2023 | 698 KB | |
| 3_BLA 125742 0_05 20 2021_Telecon_Information Reques.pdf | November 1, 2023 | 747 KB | |
| 3_IND_19736_243_19 Mar 2021_KERRY_KERRY__RO_.pdf | November 1, 2023 | 696 KB | |
| 1_BLA 125742 0_05 13 2021_Letter_Acknowledgement Let.pdf | November 1, 2023 | 713 KB | |
| 1_IND_19736_185_23 Feb 2021_KERRY_KERRY__RO_.pdf | November 1, 2023 | 697 KB | |
| 60_BLA 125742 0_08 11 2021_Telecon_Information Reques.pdf | November 1, 2023 | 764 KB | |
| 61_BLA 125742 0_08 11 2021_Telecon_Other.pdf | November 1, 2023 | 719 KB | |
| 55_BLA 125742 0_08 09 2021_Telecon_Advice.pdf | November 1, 2023 | 2 MB | |
| 58_2_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdf | November 1, 2023 | 755 KB | |
| 53_2_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdf | November 1, 2023 | 765 KB | |
| 54_BLA 125742 0_08 09 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 1 MB | |
| 51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdf | November 1, 2023 | 279 KB | |
| 52_1_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdf | November 1, 2023 | 1 MB | |
| 49_BLA 125742 0_08 06 2021_Letter_UNII Code Notificat.pdf | November 1, 2023 | 766 KB | |
| 019736_S70_M5_vr mqr 10211 10212 dlq.pdf | October 1, 2023 | 663 KB | |
| 125742_S5_M3_guidelines travel red zone belgium.pdf | October 1, 2023 | 643 KB | |
| 125742_S5_M3_requirements travel belgium.pdf | October 1, 2023 | 635 KB | |
| 019736_S157_M1_cover.pdf | October 1, 2023 | 668 KB | |
| 019736_S387_M5_c4591012 interim sponsor signature.pdf | October 1, 2023 | 664 KB | |
| 19736_S0289_M1_cover.pdf | October 1, 2023 | 687 KB | |
| 019736_S387_M5_c4591008 interim excluded subjects.pdf | October 1, 2023 | 684 KB | |
| 19736_S0369_M1_cover.pdf | October 1, 2023 | 704 KB | |
| 019736_S70_M1_cover.pdf | October 1, 2023 | 689 KB | |
| 19736_S0185_M1_cover.pdf | October 1, 2023 | 687 KB | |
| 19736_S0214_M1_cover.pdf | October 1, 2023 | 716 KB | |
| 019736_S70_M5_vr mqr 10211 10212 pq.pdf | October 1, 2023 | 708 KB | |
| 19736_S0243_M1_cover.pdf | October 1, 2023 | 733 KB | |
| 3_PM_S89_BLA 125742 5_09 21 2021_Telecon_Other.pdf | October 1, 2023 | 724 KB | |
| 19736_S0408_M1_cover.pdf | October 1, 2023 | 736 KB | |
| 19736_S0335_M1_cover.pdf | October 1, 2023 | 735 KB | |
| 19736_S0453_M1_cover.pdf | October 1, 2023 | 739 KB | |
| 19736_S0366_M1_cover.pdf | October 1, 2023 | 736 KB | |
| 125742_S2_M5_5.4_who 2005.pdf | October 1, 2023 | 747 KB | |
| 19736_S0491_M1_cover.pdf | October 1, 2023 | 742 KB | |
| 125742_2_BLA 125742 0_05 18 2021_Telecon_Information Reques.pdf | October 1, 2023 | 742 KB | |
| 019736_S414_M1_cover.pdf | October 1, 2023 | 753 KB | |
| 125742_S2_M5_5.4_who 2019.pdf | October 1, 2023 | 747 KB | |
| 019736_S488_M1_cover.pdf | October 1, 2023 | 756 KB | |
| 019736_S222_M1_cover.pdf | October 1, 2023 | 754 KB | |
| 5_PM_S102_1_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdf | October 1, 2023 | 782 KB | |
| 019736_S444_M5_c4591007 p2 3 older child assent lower dose eval.pdf | October 1, 2023 | 773 KB | |
| 019736_S196_M1_cover.pdf | October 1, 2023 | 759 KB | |
| 019736_S444_M5_c4591007 p1 older children assent lower dose eval icd.pdf | October 1, 2023 | 786 KB | |
| 6_PM_S102_2_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdf | October 1, 2023 | 783 KB | |
| 019736_S387_M5_c4591008 interim protocol deviations.pdf | October 1, 2023 | 633 KB | |
| 125742_S2_M1_356h.pdf | October 1, 2023 | 813 KB | |
| 7_PM_S102_BLA 125742 8_09 29 2021_Letter_Waiver Request.pdf | October 1, 2023 | 830 KB | |
| 19736_S0185_M1_1571.pdf | October 1, 2023 | 827 KB | |
| 019736_S387_M5_c4591008 interim sponsor signature.pdf | October 1, 2023 | 824 KB | |
| 019736_S488_M5_c4591007 p2 3 older children assent troponin icd.pdf | October 1, 2023 | 837 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 parent icd pbo controlled selected dose.pdf | October 1, 2023 | 880 KB | |
| 019736_S222_M5_c4591020 informed consent form.pdf | October 1, 2023 | 867 KB | |
| 019736_S444_M5_c4591007 p2 3 adult participant icd lower dose eval.pdf | October 1, 2023 | 966 KB | |
| 9_PM_S105_BLA 125742 9_09 20 2021_Telecon_Advice.pdf | October 1, 2023 | 941 KB | |
| 4_PM_S89_BLA 125742 5_09 22 2021_Telecon_Advice.pdf | October 1, 2023 | 983 KB | |
| 019736_S444_M5_c4591007 p1 adult participant icd lower dose eval.pdf | October 1, 2023 | 974 KB | |
| 019736_S444_M5_c4591007 p1 parent icd lower dose eval.pdf | October 1, 2023 | 995 KB | |
| 019736_S444_M5_c4591007 p2 3 parent icd lower dose eval.pdf | October 1, 2023 | 988 KB | |
| 1_PM_S85_BLA 125742 4_09 30 2021_Telecon_Advice.pdf | October 1, 2023 | 1,014 KB | |
| 019736_S488_M5_c4591007 p2 3 younger children assent troponin icd.pdf | October 1, 2023 | 1,013 KB | |
| 019736_S70_M5_vr sop lc 11120.pdf | October 1, 2023 | 1,020 KB | |
| 8_PM_S102_BLA 125742 8_09 29 2021_Telecon_Other.pdf | October 1, 2023 | 1,016 KB | |
| 2_PM_S89_BLA 12572 5_09 10 2021_Telecon_Advice.pdf | October 1, 2023 | 1 MB | |
| 019736_S444_M5_c4591007 p2 3 parent icd pbo controlled selected dose.pdf | October 1, 2023 | 1 MB | |
| 019736_S488_M5_c4591007 p2 3 parent troponin icd.pdf | October 1, 2023 | 1 MB | |
| 019736_S470_M1_cover.pdf | October 1, 2023 | 795 KB | |
| 019736_S268_M5_wi255886 sap.pdf | October 1, 2023 | 1 MB | |
| 019736_S268_M5_wi255886 protocol.pdf | October 1, 2023 | 1 MB | |
| 019736_S387_M5_c4591008 interim withdrawn subjects.pdf | October 1, 2023 | 1 MB | |
| 019736_S387_M5_c4591008 interim unplanned hospitalization.pdf | October 1, 2023 | 1 MB | |
| 019736_S196_M5_c4591008 protocol.pdf | October 1, 2023 | 1 MB | |
| 019736_S70_M5_vr mqr 10214 att01 shi sop 10011.pdf | October 1, 2023 | 1 MB | |
| 019736_S387_M5_c4591008 interim sample icd.pdf | October 1, 2023 | 1 MB | |
| 019736_S31_M1_response ir 06jul2020 c4591001.pdf | October 1, 2023 | 1 MB | |
| 019736_S70_M5_vr tm 10293.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p2 3 younger child assent lower dose eval.pdf | October 1, 2023 | 1 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 investigators.pdf | October 1, 2023 | 2 MB | |
| 125742_S1_M5_5351_c4591001 fa interim investigators.pdf | October 1, 2023 | 2 MB | |
| 019736_S387_M5_c4591008 interim non hospitalization.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr tm 10294.pdf | October 1, 2023 | 2 MB | |
| 125742_S75_M1_356h.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p1 younger children assent lower dose eval icd.pdf | October 1, 2023 | 2 MB | |
| 019736_S488_M5_c4591007 p2 3 parent icd pbo controlled selected dose track.pdf | October 1, 2023 | 2 MB | |
| 019736_S387_M5_c4591008 interim demographics.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p2 3 children assent cont select dose icd.pdf | October 1, 2023 | 2 MB | |
| 019736_S398_M1_cover.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10214 att03.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10214 att02.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10214 att01.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p2 3 parent icd pbo controlled selected dose track.pdf | October 1, 2023 | 2 MB | |
| 019736_S31_M1_cover.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p2 3 children assent pbo cont select dose icd track.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10212 att01.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10211 att01.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10212.pdf | October 1, 2023 | 2 MB | |
| 019736_S31_M5_vr mqr 10214 att01 shi sop 10011.pdf | October 1, 2023 | 2 MB | |
| 019736_S470_M5_c4591009 protocol.pdf | October 1, 2023 | 2 MB | |
| 019736_S488_M5_c4591007 p2 3 parent addendum icd pbo cont selected dose.pdf | October 1, 2023 | 2 MB | |
| 019736_S222_M5_c4591020 protocol.pdf | October 1, 2023 | 1 MB | |
| 125742_S6_M5_5351_c4591001 sequencing report.pdf | October 1, 2023 | 2 MB | |
| 019736_S31_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S325_M1_cover.pdf | October 1, 2023 | 2 MB | |
| 019736_S470_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0491_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S488_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0366_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0335_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S398_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S296_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0369_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0408_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0289_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0243_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0453_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S196_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S268_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S427_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S325_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S414_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S222_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S387_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0214_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10214.pdf | October 1, 2023 | 2 MB | |
| 019736_S157_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S325_M5_c4591020 sap.pdf | October 1, 2023 | 3 MB | |
| 019736_S31_M5_vr mqr 10214.pdf | October 1, 2023 | 2 MB | |
| 019736_S31_M5_vr tm 10294.pdf | October 1, 2023 | 3 MB | |
| 019736_S31_M5_vr tm 10293.pdf | October 1, 2023 | 3 MB | |
| 019736_S70_M5_vr mqr 10211.pdf | October 1, 2023 | 3 MB | |
| 019736_S325_M5_c4591020 sap track.pdf | October 1, 2023 | 3 MB | |
| 019736_S444_M1_cover.pdf | October 1, 2023 | 3 MB | |
| 019736_S387_M5_c4591008 interim abstract.pdf | October 1, 2023 | 3 MB | |
| 019736_S470_M5_c4591012 protocol track.pdf | October 1, 2023 | 3 MB | |
| 125742_S2_M5_5.4_sedic m 2020.pdf | October 1, 2023 | 3 MB | |
| 019736_S387_M5_c4591012 interim abstract.pdf | October 1, 2023 | 3 MB | |
| 019736_S268_M5_c4591014 protocol.pdf | October 1, 2023 | 3 MB | |
| 125742_S1_M5_5351_c4591001 fa interim interlab standard.pdf | October 1, 2023 | 3 MB | |
| 125742_S2_M1_environmental analysis.pdf | October 1, 2023 | 3 MB | |
| 019736_S268_M1_cover.pdf | October 1, 2023 | 3 MB | |
| 019736_S70_M1_response ir 29jul2020 clin assay qual.pdf | October 1, 2023 | 3 MB | |
| 019736_S398_M1_response 30june2021 icd myo peri.pdf | October 1, 2023 | 3 MB | |
| 019736_S157_M5_vr mvp 10074.pdf | October 1, 2023 | 3 MB | |
| 019736_S31_M5_vr mqr 10211.pdf | October 1, 2023 | 3 MB | |
| 019736_S31_M5_vr mqr 10212.pdf | October 1, 2023 | 3 MB | |
| 125742_S6_M5_5314_vr vtn 10436.pdf | October 1, 2023 | 2 MB | |
| 125742_S29_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S3_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S40_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S37_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S6_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S32_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S44_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S34_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S14_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S8_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S36_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S35_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S4_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S42_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S12_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S10_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S7_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S9_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S5_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S13_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S24_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S16_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S43_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S21_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S30_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S23_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S19_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S26_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S27_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S31_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S22_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S25_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S11_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S46_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S45_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S33_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S41_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S38_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S20_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S18_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S28_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S39_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S17_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S80_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S78_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S67_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S72_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S59_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S74_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S79_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S60_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 019736_S387_M5_c4591008 interim sap.pdf | October 1, 2023 | 4 MB | |
| 125742_S15_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 019736_S196_M5_c4591011 protocol.pdf | October 1, 2023 | 4 MB | |
| 125742_S56_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S105_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S89_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S69_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S113_M1_356h.pdf | October 1, 2023 | 4 MB | |
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| 125742_S112_M1_356h.pdf | October 1, 2023 | 4 MB | |
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| 125742_S102_M1_356h.pdf | October 1, 2023 | 4 MB | |
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| 125742_S136_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S73_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S85_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S70_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S68_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S64_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S82_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 019736_S387_M5_c4591008 interim protocol.pdf | October 1, 2023 | 4 MB | |
| 125742_S55_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 019736_S470_M5_c4591012 protocol.pdf | October 1, 2023 | 4 MB | |
| 125742_S50_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S49_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S47_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S48_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S52_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S51_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S53_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S2_M5_5.4_singh dk 2020.pdf | October 1, 2023 | 8 MB | |
| 19736_S0185_M1_smsr 01dec2020 31dec2020.pdf | October 1, 2023 | 9 MB | |
| 019736_S387_M1_cover.pdf | October 1, 2023 | 11 MB | |
| 019736_S196_M5_c4591012 protocol.pdf | October 1, 2023 | 13 MB | |
| 19736_S0214_M1_smsr 01jan2021 31jan2021.pdf | October 1, 2023 | 15 MB | |
| 019736_S268_M5_wi235284 protocol.pdf | October 1, 2023 | 16 MB | |
| 019736_S414_M5_c4591001 amendment 17 clean.pdf | October 1, 2023 | 16 MB | |
| 019736_S414_M5_c4591001 amendment 17 track.pdf | October 1, 2023 | 16 MB | |
| 019736_S387_M5_c4591012 interim protocol.pdf | October 1, 2023 | 17 MB | |
| 019736_S387_M5_c4591012 interim report body.pdf | October 1, 2023 | 5 MB | |
| 019736_S387_M5_c4591008 interim report body.pdf | October 1, 2023 | 6 MB | |
| 019736_S387_M5_c4591008 interim compliance.pdf | October 1, 2023 | 7 MB | |
| 019736_S488_M5_c4591007 protocol amend3 track.pdf | October 1, 2023 | 23 MB | |
| 19736_S0369 dsur 22apr2020 21apr2021.pdf | October 1, 2023 | 23 MB | |
| 019736_S444_M5_c4591007 protocol amend2 track.pdf | October 1, 2023 | 23 MB | |
| 019736_S444_M5_c4591007 protocol amend2.pdf | October 1, 2023 | 24 MB | |
| 19736_S0243 smsr 01feb2021 28feb2021.pdf | October 1, 2023 | 31 MB | |
| 19736_S0289_M1_smsr 01mar2021 31mar2021.pdf | October 1, 2023 | 37 MB | |
| 125742_S1_M1_meeting correspondence.pdf | October 1, 2023 | 21 MB | |
| 019736_S488_M5_c4591007 protocol amend3.pdf | October 1, 2023 | 22 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 reports.pdf | October 1, 2023 | 73 MB | |
| 19736_S0408_M1_smsr 01jun2021 30jun2021.pdf | October 1, 2023 | 76 MB | |
| 19736_S0335 M1_smsr 01apr2021 29apr2021.pdf | October 1, 2023 | 59 MB | |
| 19736_S0366_M1_smsr 30apr2021 31may2021.pdf | October 1, 2023 | 67 MB | |
| 19736_S0491_M1_smsr-01aug2021-31aug2021.pdf | October 1, 2023 | 100 MB | |
| 19736_S0453_M1_smsr-01jul2021-31jul2021.pdf | October 1, 2023 | 100 MB | |
| 125742_S0136_M5_smsr-01sep2021-30sep2021.pdf | October 1, 2023 | 112 MB | |
| FDA CBER 2021 5683 1053274 1058198_125742_S1_M5_C4591001 S D mh.zip (xpt) | September 1, 2023 | 11 MB | |
| FDA CBER 2021 5683 1049660 1051265_125742_S1_M5_C4591001 S D ho.zip (xpt) | September 1, 2023 | 734 KB | |
| FDA CBER 2021 5683 1051266 1053273_125742_S1_M5_C4591001 S D lb.zip (xpt) | September 1, 2023 | 2 MB | |
| FDA CBER 2021 5683 1045840 1049564_125742_S1_M5_C4591001 S D co.zip (xpt) | September 1, 2023 | 1 MB | |
| FDA CBER 2021 5683 1049565 1049659_125742_S1_M5_C4591001 S D faho.zip (xpt) | September 1, 2023 | 80 KB | |
| FDA CBER 2021 5683 1040915 1045839_125742_S1_M5_C4591001 A D admh.zip (xpt) | September 1, 2023 | 23 MB | |
| FDA CBER 2021 5683 1071968 1071995_125742_S6_M5_c45941001 S D xb.zip (xpt) | September 1, 2023 | 25 KB | |
| FDA CBER 2021 5683 1040914_125742_S1_M5_bnt162 01 S D mh.zip (xpt) | September 1, 2023 | 6 KB | |
| FDA CBER 2021 5683 1067563 1070765_125742_S6_M5_c4591001 S D ex.zip (xpt) | September 1, 2023 | 2 MB | |
| FDA CBER 2021 5683 1070766 1071967_125742_S6_M5_c45941001 S D dm.zip (xpt) | September 1, 2023 | 1 MB | |
| FDA CBER 2021 5683 1066333 1067534_125742_S6_M5_c4591001 A D adsl.zip (xpt) | September 1, 2023 | 7 MB | |
| FDA CBER 2021 5683 1067535 1067562_125742_S6_M5_c4591001 A D adxb.zip (xpt) | September 1, 2023 | 47 KB | |
| FDA CBER 2021 5683 1058199 1058203_125742_S1_M5_C4591001 S D suppie.zip (xpt) | September 1, 2023 | 7 KB | |
| FDA CBER 2021 5683 1058209 1060003_28A_2 c4591001 safety fa eff.xlsx | September 1, 2023 | 3 MB | |
| FDA CBER 2021 5683 1060004 1060071_28B_3 bnt162 01.xlsx | September 1, 2023 | 133 KB | |
| FDA CBER 2021 5683 1060085_28E_IND27034 BNT162 01 AEACN is DRUG WITHDRAWN but no ADVERSE EVENT record in DS.xlsx | September 1, 2023 | 11 KB | |
| FDA CBER 2021 5683 1071996 1072061_125742_S6_M5_define.xml | September 1, 2023 | 283 KB | |
| FDA CBER 2021 5683 1072062 1072080_125742_S6_M5_define 1.xml | September 1, 2023 | 74 KB | |
| FDA CBER 2021 5683 1064475 1066330_28K_Part III CoreDF IND27034 c4591001 subset 2021 04 19T10 50.xlsx | September 1, 2023 | 3 MB | |
| FDA CBER 2021 5683 1060090 1064473_28I_Part II CoreDF IND27034 12 15years.xlsx | September 1, 2023 | 7 MB | |
| FDA CBER 2021 5683 1064474_28J_Part II IND27034 12 15years AEACN of DRUG WITHDRAWN but no DS ADVERSE EVENT record (1).xlsx | September 1, 2023 | 16 KB | |
| FDA CBER 2021 5683 1060089_28H_IND27034 c4591001 safety fa eff AEACN is DRUG WITHDRAWN but no ADVERSE EVENT record in DS.xlsx | September 1, 2023 | 14 KB | |
| FDA CBER 2021 5683 1060086 1060087_28F_IND27034 BNT162 01 Multiple baseline records in LB.xlsx | September 1, 2023 | 26 KB | |
| FDA CBER 2021 5683 1060088_28G_IND27034 BNT162 01 Multiple baseline records in VS.xlsx | September 1, 2023 | 16 KB | |
| 125742_S1_M5_CRF_c4591001 1095 10951228.pdf | September 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951206.pdf | September 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951197.pdf | September 1, 2023 | 5 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951204.pdf | September 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951180.pdf | September 1, 2023 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1095 10951134.pdf | September 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951141.pdf | September 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951125.pdf | September 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1093 10931141.pdf | September 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951009.pdf | September 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1093 10931128.pdf | September 1, 2023 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1093 10931067.pdf | September 1, 2023 | 1 MB | |
| 125742_S54_M1_vial rl 7302 rocky mount hospira.pdf | September 1, 2023 | 695 KB | |
| 125742_S79_M1_cover.pdf | September 1, 2023 | 2 MB | |
| 125742_S54_M1_diluent carton fresenius kabi.pdf | September 1, 2023 | 730 KB | |
| 125742_S54_M1_diluent vial fresenius kabi.pdf | September 1, 2023 | 717 KB | |
| 125742_S38_M1_response 22jul2021.pdf | September 1, 2023 | 2 MB | |
| 125742_S54_M1_carton ca 7114 rocky mount hospira.pdf | September 1, 2023 | 679 KB | |
| 125742_S38_M1_cover.pdf | September 1, 2023 | 2 MB | |
| 125742_S6_M5_adrg.pdf | September 1, 2023 | 776 KB | |
| 125742_S6_M5_csdrg.pdf | September 1, 2023 | 814 KB | |
| 125742_S1_M5_CRF_c4591001 1095 10951256.pdf | September 1, 2023 | 1 MB | |
| 125742_S6_M5_acrf.pdf | September 1, 2023 | 3 MB | |
| 106_2_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 822 KB | |
| 104A_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdf | September 1, 2023 | 675 KB | |
| 104B_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdf | September 1, 2023 | 675 KB | |
| 97_1_BLA 125742 0_08 19 2021_Telecon_Information Reques.pdf | September 1, 2023 | 785 KB | |
| 98_BLA 125742 0_08 19 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 784 KB | |
| 104_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdf | September 1, 2023 | 747 KB | |
| 91_2_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 754 KB | |
| 96_2_BLA 125742 0_08 19 2021_Telecon_Information Reques.pdf | September 1, 2023 | 756 KB | |
| 88_2_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf | September 1, 2023 | 746 KB | |
| 90_1_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 810 KB | |
| 76_BLA 125742 0_08 16 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 793 KB | |
| 80_2_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf | September 1, 2023 | 782 KB | |
| 82_BLA 125742 0_08 17 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 731 KB | |
| 71_6_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 790 KB | |
| 72_BLA 125742 0_08 13 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 753 KB | |
| 69_1_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 802 KB | |
| 70_2_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 792 KB | |
| 125742_S1_M5_5351_c4591001 interim mth6 narrative sensitive.pdf | September 1, 2023 | 22 MB | |
| 67_3_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 866 KB | |
| 125742_S1_M5_5351_c4591001 interim mth6 compliance.pdf | September 1, 2023 | 94 MB | |
| 114_2_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 784 KB | |
| 112A_1_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdf | September 1, 2023 | 766 KB | |
| 113_2_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdf | September 1, 2023 | 874 KB | |
| 112_1_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdf | September 1, 2023 | 747 KB | |
| 59_1_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdf | September 1, 2023 | 759 KB | |
| 50_BLA 125742 0_08 06 2021_Memo_Committee Memo_APLB.pdf | September 1, 2023 | 771 KB | |
| 56_BLA 125742 0_08 09 2021_Telecon_Information Reques.pdf | September 1, 2023 | 755 KB | |
| 57_BLA 125742 0_08 09 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 789 KB | |
| 48A_BLA 125742 0_08 05 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 3 MB | |
| 43_2_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf | September 1, 2023 | 1 MB | |
| 48_BLA 125742 0_08 05 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 750 KB | |
| 37_BLA 125742 0_07 29 2021_Telecon_Information Reques.pdf | September 1, 2023 | 804 KB | |
| 38_1_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdf | September 1, 2023 | 785 KB | |
| 41_1_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdf | September 1, 2023 | 757 KB | |
| 35_BLA 125742 0_07 28 2021_Telecon_Information Reques.pdf | September 1, 2023 | 776 KB | |
| 36_BLA 125742 0_07 28 2021_Telecon_Labeling Target Cl.pdf | September 1, 2023 | 746 KB | |
| 31_2_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdf | September 1, 2023 | 810 KB | |
| 34_2_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdf | September 1, 2023 | 742 KB | |
| 29_BLA 125742 0_07 20 2021_Telecon_Information Reques.pdf | September 1, 2023 | 748 KB | |
| 30_BLA 125742 0_07 22 2021_Telecon_Information Reques.pdf | September 1, 2023 | 787 KB | |
| 30A_BLA 125742 0_07 22 2021_Telecon_Information Reques.pdf | September 1, 2023 | 946 KB | |
| 28D_BLA 125742 0_07 20 2021_Memo_Review.pdf | September 1, 2023 | 864 KB | |
| 28L_BLA 125742 0_07 20 2021_Memo_Review.pdf | September 1, 2023 | 744 KB | |
| 28_BLA 125742 0_07 20 2021_Memo_Review.pdf | September 1, 2023 | 697 KB | |
| 28C_BLA 125742 0_07 20 2021_Memo_Review.pdf | September 1, 2023 | 783 KB | |
| 23_1_BLA 125742 0_07 15 2021_Telecon_Information Reques.pdf | September 1, 2023 | 739 KB | |
| 24_2_BLA 125742 0_07 15 2021_Telecon_Information Reques.pdf | September 1, 2023 | 733 KB | |
| 20_1_BLA 125742 0_07 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 734 KB | |
| 22_BLA 125742 0_07 15 2021_Meeting Summary_Committee.pdf | September 1, 2023 | 1 MB | |
| 16_BLA 125742 0_07 06 2021_Telecon_Information Reques.pdf | September 1, 2023 | 735 KB | |
| 17_BLA 125742 0_07 06 2021_Telecon_Advice_PNR Accepta.pdf | September 1, 2023 | 728 KB | |
| 19_2_BLA 125742 0_07 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 748 KB | |
| 12_BLA 125742 0_07 01 2021_Memo_Filing Checklist_RPM.pdf | September 1, 2023 | 1 MB | |
| 14_BLA 125742 0_07 02 2021_Telecon_Advice.pdf | September 1, 2023 | 770 KB | |
| 9_2_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdf | September 1, 2023 | 812 KB | |
| 11_BLA 125742 0_06 29 2021_Telecon_Information Reques.pdf | September 1, 2023 | 701 KB | |
| 5_BLA 125742 0_06 08 2021_Telecon_Information Reques.pdf | September 1, 2023 | 766 KB | |
| 6_BLA 125742 0_06 09 2021_Telecon_Information Reques.pdf | September 1, 2023 | 732 KB | |
| 63_BLA 125742 0_08 12 2021_Telecon_Other.pdf | September 1, 2023 | 691 KB | |
| FDA CBER 2021 5683 1072126 1072170_125742_S6_M5_define2 0 0 2.zip (xsl) | September 1, 2023 | 27 KB | |
| FDA CBER 2021 5683 1072081 1072125_125742_S6_M5_define2 0 0.zip (xsl) | September 1, 2023 | 27 KB | |
| FDA-CBER-2021-5683-1007285-1007313_125742_S2_M1_lab-1448-0-1-pkg-insert-clean.doc | August 1, 2023 | 533KB | |
| 125742_S1_M5_CRF_c4591001 1089 10891182.pdf | August 1, 2023 | 4 MB | |
| 125742_S1_M5_CRF_c4591001 1072 10721007.pdf | August 1, 2023 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1077 10771049.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1077 10771137.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1077 10771194.pdf | August 1, 2023 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1079 10791228.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1080 10801006.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1080 10801013.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1080 10801035.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1080 10801059.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1080 10801152.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1082 10821076.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1082 10821083.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1082 10821094.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831023.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1082 10821149.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831029.pdf | August 1, 2023 | 4 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831050.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831060.pdf | August 1, 2023 | 5 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831124.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831162.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831173.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1084 10841141.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1084 10841219.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1084 10841266.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1084 10841317.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1084 10841470.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1084 10841480.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1087 10871070.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871029.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871121.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1087 10871150.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871191.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871228.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871266.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871286.pdf | August 1, 2023 | 4 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871289.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871355.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871354.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1088 10881126.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871557.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1088 10881139.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1088 10881220.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891042.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891073.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891065.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891088.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891181.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891150.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1142 11421073.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1142 11421084.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891273.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891289.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1094 10941112.pdf | August 1, 2023 | 5 MB | |
| 125742_S1_M5_CRF_c4591001 1094 10941155.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971011.pdf | August 1, 2023 | 39 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971017.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971023.pdf | August 1, 2023 | 18 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971026.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971025.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971031.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971061.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971064.pdf | August 1, 2023 | 25 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971084.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971087.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1098 10981024.pdf | August 1, 2023 | 6 MB | |
| 125742_S1_M5_CRF_c4591001 1101 11011115.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1107 11071031.pdf | August 1, 2023 | 4 MB | |
| 125742_S1_M5_CRF_c4591001 1107 11071044.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1109 11091204.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1109 11091269.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 4444 44441634.pdf | August 1, 2023 | 22 MB | |
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| 125742_S1_M5_CRF_c4591001 4444 44442304.pdf | August 1, 2023 | 2 MB | |
| 125742_S45_M1_response 09aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S2_M1_lab 1448 0 1 annotated.pdf | August 1, 2023 | 1 MB | |
| 125742_S2_M1_lab 1448 0 1 pkg insert clean.pdf | August 1, 2023 | 1 MB | |
| 125742_S2_M1_loa dmf 15209 vials.pdf | August 1, 2023 | 960 KB | |
| 125742_S2_M1_pharmacovigilance plan.pdf | August 1, 2023 | 13 MB | |
| 125742_S6_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S7_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S6_M5_c4591001_adxb sas.pdf | August 1, 2023 | 621 KB | |
| 125742_S8_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S9_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S9_M1_response 29jun2021.pdf | August 1, 2023 | 714 KB | |
| 125742_S10_M1_response 25jun2021.pdf | August 1, 2023 | 716 KB | |
| 125742_S10_M1_appendix 1.pdf | August 1, 2023 | 730 KB | |
| 125742_S10_M1_cover.pdf | August 1, 2023 | 696 KB | |
| 125742_S13_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S12_M1_cover.pdf | August 1, 2023 | 668 KB | |
| 125742_S16_M1_cover.pdf | August 1, 2023 | 673 KB | |
| 125742_S13_M1_response 06july2021.pdf | August 1, 2023 | 767 KB | |
| 125742_S16_M1_ped studies deferral req.pdf | August 1, 2023 | 11 MB | |
| 125742_S16_M1_psp agreed clean.pdf | August 1, 2023 | 2 MB | |
| 125742_S16_M1_response 15jul2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S18_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S18_M1_response 22jul2021.pdf | August 1, 2023 | 749 KB | |
| 125742_S20_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S20_M1_response 22jul2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S23_M1_response 26jul2021.pdf | August 1, 2023 | 764 KB | |
| 125742_S23_M1_cover.pdf | August 1, 2023 | 673 KB | |
| 125742_S21_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S24_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S27_M1_cover.pdf | August 1, 2023 | 672 KB | |
| 125742_S28_M1_cover.pdf | August 1, 2023 | 673 KB | |
| 125742_S24_M1_response 27jul2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S31_M1_cover.pdf | August 1, 2023 | 672 KB | |
| 125742_S29_M1_cover.pdf | August 1, 2023 | 721 KB | |
| 125742_S32_M1_cover.pdf | August 1, 2023 | 1 MB | |
| 125742_S31_M1_response 28jul2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S32_M1_response 02aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S33_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S33_M5_c4591001_adc19ef ve sev 7pd2 cdc wo eval sas.pdf | August 1, 2023 | 608 KB | |
| 125742_S33_M1_response 22jul 03aug.pdf | August 1, 2023 | 2 MB | |
| 125742_S33_M5_c4591001_adc19ef ve sev 7pd2 cdc eval sas.pdf | August 1, 2023 | 608 KB | |
| 125742_S39_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S41_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S41_M1_response 10aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S41_M5_5354_c4591021 protocol.pdf | August 1, 2023 | 14 MB | |
| 125742_S45_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S77_M1_response 21aug2021 pmc.pdf | August 1, 2023 | 1 MB | |
| 125742_S78_M1_attachment hcp letter.pdf | August 1, 2023 | 742 KB | |
| 125742_S46_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S49_M1_cover.pdf | August 1, 2023 | 672 KB | |
| 125742_S49_M1_response 13aug2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S51_M1_cover.pdf | August 1, 2023 | 720 KB | |
| 125742_S54_M1_cover.pdf | August 1, 2023 | 721 KB | |
| 125742_S52_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S52_M1_response 13aug2021.pdf | August 1, 2023 | 817 KB | |
| 125742_S54_M1_response 16aug2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S58_M1_cover.pdf | August 1, 2023 | 720 KB | |
| 125742_S62_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S64_M1_carton ca 7114 hospira.pdf | August 1, 2023 | 676 KB | |
| 125742_S64_M1_cover.pdf | August 1, 2023 | 732 KB | |
| 125742_S62_M1_response 17aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S64_M1_diluent vial fresenius kabi.pdf | August 1, 2023 | 715 KB | |
| 125742_S64_M1_diluent carton fresenius kabi.pdf | August 1, 2023 | 728 KB | |
| 125742_S65_M1_2253.pdf | August 1, 2023 | 1,024 KB | |
| 125742_S64_M1_vial diluent rl 7302 hospira.pdf | August 1, 2023 | 670 KB | |
| 125742_S65_M1_eua lab 1450 12 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S65_M1_eua lab 1451 8 0.pdf | August 1, 2023 | 700 KB | |
| 125742_S65_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S66_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S66_M1_eua lab 1450 12 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S66_M1_eua lab 1451 8 0.pdf | August 1, 2023 | 697 KB | |
| 125742_S66_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S67_M1_attachment hcp letter.pdf | August 1, 2023 | 661 KB | |
| 125742_S67_M1_attachment infographic lots.pdf | August 1, 2023 | 637 KB | |
| 125742_S66_M1_pp cvv usa 0357.pdf | August 1, 2023 | 19 MB | |
| 125742_S67_M1_cover.pdf | August 1, 2023 | 673 KB | |
| 125742_S67_M1_response 18aug2021.pdf | August 1, 2023 | 715 KB | |
| 125742_S68_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S69_M1_cover.pdf | August 1, 2023 | 668 KB | |
| 125742_S69_M1_response 19aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S70_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S71_M1_cover.pdf | August 1, 2023 | 672 KB | |
| 125742_S71_M1_response 19aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S72_M1_cover.pdf | August 1, 2023 | 696 KB | |
| 125742_S72_M1_letter of authorization.pdf | August 1, 2023 | 654 KB | |
| 125742_S73_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S74_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S74_M1_response 20aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S75_M1_attachment hcp letter.pdf | August 1, 2023 | 753 KB | |
| 125742_S75_M1_attachment infographic lots.pdf | August 1, 2023 | 4 MB | |
| 125742_S75_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S76_M1_cover.pdf | August 1, 2023 | 721 KB | |
| 125742_S75_M1_response 20aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S77_M1_response 21aug2021 attachment pmc.pdf | August 1, 2023 | 2 MB | |
| 125742_S77_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S118_M1_pp cvv usa 0426.pdf | August 1, 2023 | 830 KB | |
| 125742_S85_M1_cover.pdf | August 1, 2023 | 779 KB | |
| 125742_S78_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S82_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S87_m1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S87_M1_2253 multiple product.pdf | August 1, 2023 | 588 KB | |
| 125742_S87_M1_eua lab 1450 12 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S87_M1_lab 0722 9 0.pdf | August 1, 2023 | 753 KB | |
| 125742_S87_M1_eua lab 1451 8 0.pdf | August 1, 2023 | 700 KB | |
| 125742_S87_M1_lab 0469 18 0.pdf | August 1, 2023 | 901 KB | |
| 125742_S87_M1_lab 1436 1 0.pdf | August 1, 2023 | 856 KB | |
| 125742_S87_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S87_M1_pp pna usa 4653.pdf | August 1, 2023 | 2 MB | |
| 125742_S88_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S88_M1_pp cvv usa 0378.pdf | August 1, 2023 | 921 KB | |
| 125742_S89_M1_comments advice req.pdf | August 1, 2023 | 1 MB | |
| 125742_S89_M1_cover.pdf | August 1, 2023 | 696 KB | |
| 125742_S94_M1_eua lab 1451 9 0.pdf | August 1, 2023 | 700 KB | |
| 125742_S94_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S94_M1_eua lab 1457 13 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S94_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S94_M1_pp cvv usa 0408.pdf | August 1, 2023 | 3 MB | |
| 125742_S102_M1_cover.pdf | August 1, 2023 | 1 MB | |
| 125742_S105_M1_req comments advice bpdr.pdf | August 1, 2023 | 689 KB | |
| 125742_S102_M1_request waiver ldr.pdf | August 1, 2023 | 2 MB | |
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| 125742_S116_M1_pp cvv usa 0387.pdf | August 1, 2023 | 1 MB | |
| 125742_S116_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S116_M1_pp cvv usa 0389.pdf | August 1, 2023 | 748 KB | |
| 125742_S117_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S117_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S117_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S117_M1_pp cvv usa 0422.pdf | August 1, 2023 | 3 MB | |
| 125742_S118_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S118_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S118_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S144_M1_lab 1457 15 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S144_M1_pp cvv usa 0478.pdf | August 1, 2023 | 9 MB | |
| 125742_S123_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S123_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S123_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S123_M1_pp cvv usa 0430.pdf | August 1, 2023 | 5 MB | |
| 125742_S125_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S125_M1_lab 1451 10 0.pdf | August 1, 2023 | 708 KB | |
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| 125742_S126_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S125_M1_pp cvv usa 0424.pdf | August 1, 2023 | 1 MB | |
| 125742_S126_M1_lab 1451 10 0.pdf | August 1, 2023 | 708 KB | |
| 125742_S126_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S129_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S126_M1_pp cvv usa 0429.pdf | August 1, 2023 | 2 MB | |
| 125742_S129_M1_lab 1451 10 0.pdf | August 1, 2023 | 710 KB | |
| 125742_S129_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S131_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S129_M1_pp cvv usa 0442.pdf | August 1, 2023 | 1 MB | |
| 125742_S131_M1_lab 1451 10 0.pdf | August 1, 2023 | 710 KB | |
| 125742_S131_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S131_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S131_M1_pp cvv usa 0391.pdf | August 1, 2023 | 1 MB | |
| 125742_S131_M1_pp cvv usa 0431.pdf | August 1, 2023 | 1 MB | |
| 125742_S131_M1_pp cvv usa 0432.pdf | August 1, 2023 | 760 KB | |
| 125742_S136_M1_cover.pdf | August 1, 2023 | 732 KB | |
| 125742_S138_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S138_M1_lab 1451 11 0.pdf | August 1, 2023 | 703 KB | |
| 125742_S138_M1_pp cvv usa 0416.pdf | August 1, 2023 | 571 KB | |
| 125742_S141_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S141_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S141_M1_lab 1457 15 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S141_M1_lab 1451 11 0.pdf | August 1, 2023 | 703 KB | |
| 125742_S141_M1_pp cvv usa 0473.pdf | August 1, 2023 | 3 MB | |
| 125742_S144_m1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S144_M1_2253.pdf | August 1, 2023 | 895 KB | |
| 125742_S144_M1_lab 1451 11 0.pdf | August 1, 2023 | 703 KB | |
| FDA CBER 2021 5683 1007284_125742_S2_M1_comirnaty 12.jpg | August 1, 2023 | 295 KB | |
| FDA CBER 2021 5683 1007238 1007272_125742_S2_M1_comirnaty.xml | August 1, 2023 | 205 KB | |
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| FDA CBER 2021 5683 1007283_125742_S2_M1_comirnaty 11.jpg | August 1, 2023 | 344 KB | |
| FDA CBER 2021 5683 1007338_125742_S82_M1_comirnaty 01.jpg | August 1, 2023 | 23 KB | |
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| FDA CBER 2021 5683 1007346_125742_S82_M1_comirnaty 09.jpg | August 1, 2023 | 109 KB | |
| FDA CBER 2021 5683 1007348_125742_S82_M1_comirnaty 11.jpg | August 1, 2023 | 798 KB | |
| FDA CBER 2021 5683 1007314 1007337_125742_S82_M1_comirnaty.xml | August 1, 2023 | 139 KB | |
| FDA CBER 2021 5683 1007349_125742_S138_M1_pp cvv usa 0416.mp3 | August 1, 2023 | 243 KB | |
| 125742_S65_M1_pp cvv usa 0349 01.pdf | August 1, 2023 | 60 MB | |
| 125742_S1_M5_CRF_c4591001 1027 10271191.pdf | July 3, 2023 | 4 MB | |
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| 125742_S1_M5_CRF_c4591001 1145 11451055.pdf | May 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1145 11451042.pdf | May 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1134 11341378.pdf | May 1, 2023 | 2 MB | |
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| 125742_S1_M5_5314_vr mvr 10080 att 01.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mvr 10080.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mqr 10214 att 03.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mqr 10214 att 01.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mqr 10214 att 02.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mqr 10214.pdf | April 3, 2023 | 3 MB | |
| 125742_S1_M5_5314_vr mqr 10212 att 01.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mqr 10212.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mqr 10211.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mqr 10211 att 01.pdf | April 3, 2023 | 2 MB | |
| 125742_S14_M1_cover.pdf | April 3, 2023 | 2 MB | |
| 125742_S7_M5_5351_bnt162 01 interim3 reports.pdf | April 3, 2023 | 25 MB | |
| 125742_S4_M1_response 18 may 2021 datasets.pdf | April 3, 2023 | 714 KB | |
| 125742_S3_M1_proprietary name.pdf | April 3, 2023 | 2 MB | |
| 125742_S4_M1_cover.pdf | April 3, 2023 | 675 KB | |
| 125742_S2_M5_5354_wi255886 protocol.pdf | April 3, 2023 | 1 MB | |
| 125742_S3_M1_cover.pdf | April 3, 2023 | 705 KB | |
| 125742_S2_M5_5354_c4591022 protocol.pdf | April 3, 2023 | 3 MB | |
| 125742_S2_M5_5354_c4591014 protocol.pdf | April 3, 2023 | 3 MB | |
| 125742_S2_M5_5354_c4591012 protocol.pdf | April 3, 2023 | 15 MB | |
| 125742_S2_M5_5354_c4591011 protocol.pdf | April 3, 2023 | 5 MB | |
| 125742_S2_M5_5354_c4591009 protocol synopsis.pdf | April 3, 2023 | 2 MB | |
| 125742_S2_M5_5351_c4591015 protocol amend2.pdf | April 3, 2023 | 13 MB | |
| 125742_S2_M5_5354_c4591008 protocol.pdf | April 3, 2023 | 2 MB | |
| 125742_S2_M5_5351_c4591007 protocol amend1.pdf | April 3, 2023 | 24 MB | |
| 125742_S2_M1_pllr waiver request pregnancy registry.pdf | April 3, 2023 | 2 MB | |
| 125742_S2_M1_pllr lit search summary.pdf | April 3, 2023 | 2 MB | |
| 125742_S2_M1_pllr waiver request drug utilization.pdf | April 3, 2023 | 2 MB | |
| 125742_S2_M1_pllr cumulative review.pdf | April 3, 2023 | 2 MB | |
| 125742_S2_M1_loa dmf 9543 vials.pdf | April 3, 2023 | 609 KB | |
| 125742_S2_M1_dca vaed.pdf | April 3, 2023 | 744 KB | |
| 125742_S2_M1_diluent labeling proposal.pdf | April 3, 2023 | 2 MB | |
| 125742_S2_M1_cover.pdf | April 3, 2023 | 697 KB | |
| 125742_S2_M1_dca anaphylactic reaction.pdf | April 3, 2023 | 724 KB | |
| 125742_S1_M5_5351_c4591001 interim mth6 synopsis.pdf | April 3, 2023 | 4 MB | |
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| 125742_S1_M5_5351_c4591001 fa interim synopsis.pdf | April 3, 2023 | 1 MB | |
| 125742_S1_M5_5351_c4591001 fa interim report body.pdf | April 3, 2023 | 29 MB | |
| 125742_S1_M5_5314_vr tm 10304.pdf | April 3, 2023 | 5 MB | |
| 125742_S1_M5_5314_vr tm 10298.pdf | April 3, 2023 | 3 MB | |
| 125742_S1_M5_5314_vr tm 10294.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr sop lc 11120.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr tm 10293.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mvr 10083 att04.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mvr 10083 att02.pdf | April 3, 2023 | 1 MB | |
| 125742_S1_M5_5314_vr mvr 10083 att03.pdf | April 3, 2023 | 1 MB | |
| 125742_S1_M5_5314_vr mvr 10083 att01.pdf | April 3, 2023 | 1 MB | |
| 125742_S1_M5_5314_vr mvr 10081 att 01.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mvr 10083.pdf | April 3, 2023 | 998 KB | |
| 125742_S1_M5_5314_vr mvr 10081.pdf | April 3, 2023 | 2 MB | |
| 125742_S1_M5_5314_vr mvr 10080 att 02.pdf | April 3, 2023 | 2 MB | |
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| FDA CBER 2021 5683 0772116_125742_S1_M4_38166 D_te.zip | March 1, 2023 | 779 B | |
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| FDA CBER 2021 5683 0769012 0769013_125742_S1_M4_20gr142 D_dm.zip | March 1, 2023 | 3 KB | |
| FDA CBER 2021 5683 0769014 0769019_125742_S1_M4_38166 D_ds.zip | March 1, 2023 | 2 KB | |
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| FDA CBER 2021 5683 0768189 0768226_125742_S1_M4_38166 D_bg.zip | March 1, 2023 | 21 KB | |
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| 125742_S64_M1_carton-com25ctpus-puurs | January 3, 2023 | 242 KB | |
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| 125742_S64_M1_sticker-comdilrm.pdf | January 3, 2023 | 180 KB | |
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| 4_BLA_125742-0_06-03-2021_First_Committee_Meeting_Summary.pdf | January 3, 2023 | 772 KB | |
| 7_BLA_125742-0_06-17-2021_Memo_Other.pdf | January 3, 2023 | 682 KB | |
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| 125742_S70_M1_lab-1448-0-7-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
| 36A_BLA_125742-0_07-28-2021_Telecon_Labeling Target Cl | January 3, 2023 | 1 MB | |
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| 125742_S73_M1_lab-1448-0-8-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
| 72A_BLA_125742-0_08-13-2021_Telecon_Labeling via FAX_e.pdf | January 3, 2023 | 1 MB | |
| 77_BLA_125742-0_08-17-2021_Memo_Lot Release Clearance.pdf | January 3, 2023 | 805 KB | |
| 78_BLA_125742-0_08-17-2021_Memo_Other.pdf | January 3, 2023 | 814 KB | |
| 82A_BLA_125742-0_08-17-2021_Telecon_Labeling via FAX_e | January 3, 2023 | 1 MB | |
| 125742_S73_M1_lab-1448-0-8-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
| 91A_2_BLA_125742-0_08-18-2021_Telecon_Labeling via FAX_e.pdf | January 3, 2023 | 1 MB | |
| 125742_S76_M1_lab-1448-0-9-annotated.pdf | January 3, 2023 | 1 MB | |
| 125742_S76_M1_lab-1448-0-9-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
| 98A_BLA_125742-0_08-19-2021_Telecon_Labeling via FAX_e.pdf | January 3, 2023 | 1 MB | |
| 125742_S76_M1_lab-1448-0-9-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
| FDA-CBER-2021-5683-0650114-0650115-125742_S1_M5_c4591001-S-D-ts | December 1, 2022 | 4 KB | |
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| FDA-CBER-2021-5683-0633790-0633944-125742_S1_M5_bnt162-01-S-D-adcevd | December 1, 2022 | 133 KB | |
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| FDA-CBER-2021-5683-0600620-0616658-125742_S1_M5_c4591001-S-D-suppec | December 1, 2022 | 3 MB | |
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| FDA CBER 2021 5683 0484356 0484378 125742_S1_M5_bnt162 01 S D xa.xpt | October 3, 2022 | 502 KB | |
| FDA CBER 2021 5683 0484342 0484355 125742_S1_M5_bnt162 01 S D ae.xpt | October 3, 2022 | 423 KB | |
| FDA-CBER-2021-5683-0396255-0484341_125742_S1_M5_c4591001-S-Supp-D-suppface.xpt | September 1, 2022 | 467 MB | |
| FDA CBER 2021 5683 0396247 0396248_125742_S1_M5_bnt162 01 S D ta.xpt | September 1, 2022 | 18 KB | |
| FDA CBER 2021 5683 0396249 0396254_125742_S1_M5_bnt162 01 S D xb.xpt | September 1, 2022 | 43 KB | |
| FDA CBER 2021 5683 0396239 0396241_125742_S1_M5_bnt162 01 S D suppeg.xpt | September 1, 2022 | 13 KB | |
| FDA CBER 2021 5683 0396242 0396246_125742_S1_M5_bnt162 01 S D suppxa.xpt | September 1, 2022 | 24 KB | |
| FDA CBER 2021 5683 0396223 0396227_125742_S1_M5_bnt162 01 S D dv.xpt | September 1, 2022 | 67 KB | |
| FDA CBER 2021 5683 0396228 0396233_125742_S1_M5_bnt162 01 S D rp.xpt | September 1, 2022 | 62 KB | |
| FDA CBER 2021 5683 0396234 0396238_125742_S1_M5_bnt162 01 S D suppdv.xpt | September 1, 2022 | 56 KB | |
| FDA CBER 2021 5683 0396214 0396222_125742_S1_M5_bnt162 01 S D cm.xpt | September 1, 2022 | 200 KB | |
| FDA CBER 2021 5683 0396200 0396213_125742_S1_M5_bnt162 01 A D adae.xpt | September 1, 2022 | 804 KB | |
| FDA-CBER-2021-5683-0396199_125742_S1_M5_bnt162-01-S-D-tv.zip | August 1, 2022 | 1 KB | |
| FDA CBER 2021 5683 0396197_125742_S1_M5_bnt162 01 S D supprp.xpt | August 1, 2022 | 3 KB | |
| FDA CBER 2021 5683 0396198_125742_S1_M5_bnt162 01 S D te.xpt | August 1, 2022 | 7 KB | |
| FDA CBER 2021 5683 0396193 to 0396194_125742_S1_M5_c4591001 S D supppe.xpt | August 1, 2022 | 12 KB | |
| FDA CBER 2021 5683 0396195_125742_S1_M5_bnt162 01 S D relrec.xpt | August 1, 2022 | 2 KB | |
| FDA CBER 2021 5683 0396196_125742_S1_M5_bnt162 01 S D supppe.xpt | August 1, 2022 | 6 KB | |
| FDA CBER 2021 5683 0396187_125742_S1_M5_c4591001 S D pr.xpt | August 1, 2022 | 19 KB | |
| FDA CBER 2021 5683 0396188 to 0396192_125742_S1_M5_c4591001 S D suppmo.xpt | August 1, 2022 | 65 KB | |
| FDA CBER 2021 5683 0396199_125742_S1_M5_bnt162 01 S D tv.xpt | August 1, 2022 | 4 KB | |
| FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.xpt | August 1, 2022 | 467 MB | |
| 125742_S2_M5_54_ezeanolue e 2019.pdf | August 1, 2022 | 40 MB | |
| FDA CBER 2021 5683 0285652 to 0286071_125742_S1_M5_c4591001 S D pe.zip (xpt) | July 1, 2022 | 170 KB | |
| FDA CBER 2021 5683 0282366 to 0285643_125742_S1_M5_c4591001 S D mb.zip (xpt) | July 1, 2022 | 2 MB | |
| FDA CBER 2021 5683 0285644 to 0285651_125742_S1_M5_c4591001 S D mo.zip (xpt) | July 1, 2022 | 6 KB | |
| FDA CBER 2021 5683 0282329 to 0282365_125742_S1_M5_c4591001 S D ie.zip (xpt) | July 1, 2022 | 19 KB | |
| FDA CBER 2021 5683 0282130 to 0282328_125742_S1_M5_c4591001 S D cm.zip (xpt) | July 1, 2022 | 151 KB | |
| FDA CBER 2021 5683 0225598 to 0282129_125742_S1_M5_c4591001 A Supp D adfacevd.zip (xpt) | July 1, 2022 | 84 MB | |
| FDA CBER 2021 5683 0225100 to 0225597_125742_S1_M5_c4591001 A D adcm.zip (xpt) | July 1, 2022 | 1 MB | |
| FDA CBER 2021 5683 0296904 to 0307543_125742_S1_M5_c4591001 S D suppce.zip (xpt) | July 1, 2022 | 1 MB | |
| FDA CBER 2021 5683 0286267 to 0296903_125742_S1_M5_c4591001 S Supp D suppce.zip (xpt) | July 1, 2022 | 1 MB | |
| FDA CBER 2021 5683 0286072 to 0286266_125742_S1_M5_c4591001 S Supp D relrec.zip (xpt) | July 1, 2022 | 54 KB | |
| 125742_S1_M5_5351_c4591001 interim mth6 lab measurements sensitive.pdf | July 1, 2022 | 5 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 interlab standard.pdf | July 1, 2022 | 11 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 excluded patients sensitive.pdf | July 1, 2022 | 3 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 excluded patients.pdf | July 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 errata.pdf | July 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 efficacy response.pdf | July 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 discontinued patients.pdf | July 1, 2022 | 4 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 compliance sensitive.pdf | July 1, 2022 | 1 MB | |
| 125742_S2_M5_5354_wi235284 protocol.pdf | July 1, 2022 | 15 MB | |
| 125742_S2_M1_right of reference.pdf | July 1, 2022 | 2 MB | |
| 125742_S2_M1_loa dmf 031786 vials.pdf | July 1, 2022 | 2 MB | |
| 125742_S2_M1_loa dmf 012683 vials.pdf | July 1, 2022 | 631 KB | |
| 125742_S2_M1_loa dmf 011820 vials.pdf | July 1, 2022 | 616 KB | |
| 125742_S2_M1_loa dmf 011793 vials.pdf | July 1, 2022 | 701 KB | |
| 125742_S2_M1_loa dmf 011321 vials.pdf | July 1, 2022 | 1,019 KB | |
| 125742_S2_M1_loa dmf 10953 stopper.pdf | July 1, 2022 | 861 KB | |
| 125742_S2_M1_hospira diluent label.pdf | July 1, 2022 | 776 KB | |
| 125742_S2_M1_hospira diluent carton.pdf | July 1, 2022 | 987 KB | |
| 125742_S2_M1_fk diluent stamp.pdf | July 1, 2022 | 598 KB | |
| 125742_S2_M1_fk diluent carton.pdf | July 1, 2022 | 607 KB | |
| 125742_S2_M1_comvlabp vial puurs.pdf | July 1, 2022 | 648 KB | |
| 125742_S2_M1_comvlabkz vial kzoo.pdf | July 1, 2022 | 863 KB | |
| 125742_S2_M1_com195lpus carton puurs.pdf | July 1, 2022 | 691 KB | |
| 125742_S2_M1_com195lkz carton kzoo.pdf | July 1, 2022 | 1,024 KB | |
| 125742_S2_M1_com25ctpus carton puurs.pdf | July 1, 2022 | 672 KB | |
| 125742_S2_M1_com25ctkz carton kzoo.pdf | July 1, 2022 | 632 KB | |
| 125742_S1_M5_5351_c4591001 interim mth6 sap.pdf | July 1, 2022 | 5 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 protocol deviations.pdf | July 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001 fa interim sap.pdf | July 1, 2022 | 3 MB | |
| 125742_S1_M5_5351_c4591001 fa interim narrative sensitive.pdf | July 1, 2022 | 19 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 adverse events.zip (pdf) | July 1, 2022 | 28 MB | |
| FDA CBER 2021 5683 0208521 to 0216666_125742_S1_M5_c4591001 S Supp D suppvs.zip (xpt) | June 1, 2022 | 917 KB | |
| FDA CBER 2021 5683 0205318 to 0208520_125742_S1_M5_c4591001 S Supp D ex.zip (xpt) | June 1, 2022 | 2 MB | |
| FDA CBER 2021 5683 0196049 to 0205317_125742_S1_M5_c4591001 S Supp D ce.zip (xpt) | June 1, 2022 | 8 MB | |
| FDA CBER 2021 5683 0187906 to 0196048_125742_S1_M5_c4591001 S D suppvs.zip (xpt) | June 1, 2022 | 915 KB | |
| FDA CBER 2021 5683 0182981 to 0187905_125742_S1_M5_c4591001 S D suppmh.zip (xpt) | June 1, 2022 | 616 KB | |
| FDA CBER 2021 5683 0180191 to 0182980_125742_S1_M5_c4591001 S D suppis.zip (xpt) | June 1, 2022 | 350 KB | |
| FDA CBER 2021 5683 0178319 to 0180190_125742_S1_M5_c4591001 S D suppho.zip (xpt) | June 1, 2022 | 259 KB | |
| FDA CBER 2021 5683 0174607 to 0178318_125742_S1_M5_c4591001 S D suppdv.zip (xpt) | June 1, 2022 | 623 KB | |
| FDA CBER 2021 5683 0171524 to 0174606_125742_S1_M5_c4591001 S D suppds.zip (xpt) | June 1, 2022 | 405 KB | |
| FDA CBER 2021 5683 0169082 to 0171523_125742_S1_M5_c4591001 S D suppdm.zip (xpt) | June 1, 2022 | 334 KB | |
| FDA CBER 2021 5683 0168683 to 0169081_125742_S1_M5_c4591001 S D suppcm.zip (xpt) | June 1, 2022 | 71 KB | |
| FDA CBER 2021 5683 0165893 to 0168682_125742_S1_M5_c4591001 S D is.zip (xpt) | June 1, 2022 | 1 MB | |
| FDA CBER 2021 5683 0162690 to 0165892_125742_S1_M5_c4591001 S D ex.zip (xpt) | June 1, 2022 | 2 MB | |
| FDA CBER 2021 5683 0159487 to 0162689_125742_S1_M5_c4591001 S D ec.zip (xpt) | June 1, 2022 | 2 MB | |
| FDA CBER 2021 5683 0158560 to 0159486_125742_S1_M5_c4591001 S D dv.zip (xpt) | June 1, 2022 | 558 KB | |
| FDA CBER 2021 5683 0149082 to 0158559_125742_S1_M5_c4591001 S D ce.zip (xpt) | June 1, 2022 | 8 MB | |
| FDA CBER 2021 5683 0142307 to 0149081_125742_S1_M5_c4591001 A Supp D adcevd.zip (xpt) | June 1, 2022 | 8 MB | |
| 125742_S1_M5_CRF_c4591001 1081 10811194 reissue.pdf | June 1, 2022 | 2 MB | |
| STN 125742 0 0 Section 2.5 Clinical Overview reissue.pdf | June 1, 2022 | 5 MB | |
| 125742_S1_M5_CRF_c4591001 1128 11281009 reissue.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1015 10151101.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1015 10151089.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1015 10151071.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1015 10151238.pdf | June 1, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1015 10151225.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1015 10151134.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1015 10151035.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1015 10151011.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131786.pdf | June 1, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131718.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131699.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131658.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131656.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131653.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1015 10151047.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131517.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131386.pdf | June 1, 2022 | 1,008 KB | |
| 125742_S1_M5_CRF_c4591001 1013 10131255.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131229.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131190.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131176.pdf | June 1, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131165.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131089.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131084.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1012 10121163.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1013 10131554.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1012 10121097.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1011 10111181.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1011 10111029.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1009 10091149.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1009 10091135.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1009 10091128.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1009 10091123.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1008 10081667.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1008 10081628.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1012 10121112.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1008 10081337.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1008 10081184.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1008 10081152.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1008 10081056.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071443.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071441.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071347.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071315.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071306.pdf | June 1, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1008 10081603.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071276.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071192.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071159.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071124.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071117.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071101.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071097.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071050.pdf | June 1, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1007 10071280.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 publications.pdf | June 1, 2022 | 11 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 patient batches.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001 fa interim protocol deviations sensitive.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001 fa interim patient batches.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001 fa interim discontinued patients.pdf | June 1, 2022 | 3 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 randomization.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_5314_shi sop 10011.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M2_summary biopharm.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001 fa interim adverse events.pdf | June 1, 2022 | 32 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdf | May 2, 2022 | 634 KB | |
| 125742_S1_M5_5351_bnt162 01 interim3 investigators.pdf | May 2, 2022 | 6 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 iec irb.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 excluded patients.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 discontinued patients.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 demographics.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 compliance.pdf | May 2, 2022 | 7 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 adverse events.pdf | May 2, 2022 | 7 MB | |
| 125742_S1_M5_5351_bnt162 01_20242.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01_20215.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01_20116.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01_10075.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01_10010.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdf | May 2, 2022 | 91 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 report body.pdf | May 2, 2022 | 42 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 protocol.pdf | May 2, 2022 | 10 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 notes for reader.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdf | May 2, 2022 | 12 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdf | May 2, 2022 | 5 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdf | May 2, 2022 | 65 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdf | May 2, 2022 | 4 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 sap.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdf | May 2, 2022 | 9 MB | |
| 125742_S1_M5_c4591001 S Supp acrf.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_c4591001 S csdrg.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_c4591001 S acrf.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_bnt162 01 S csdrg.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_bnt162 01 S acrf.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_bnt162 01 A adrg.pdf | May 2, 2022 | 891 KB | |
| 125742_S1_M5_CRF_c4591001 1006 10061176.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1006 10061098.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1006 10061094.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1006 10061052.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1006 10061040.pdf | May 2, 2022 | 4 MB | |
| 125742_S1_M5_CRF_c4591001 1006 10061020.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1005 10051411.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1005 10051387.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1005 10051347.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1005 10051293.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1005 10051214.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1005 10051069.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1005 10051054.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1005 10051047.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1003 10031207.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1003 10031197.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1003 10031186.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1003 10031149.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1003 10031113.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1003 10031111.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1003 10031065.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1003 10031038.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1001 10011135.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1001 10011100.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1001 10011093.pdf | May 2, 2022 | 3 MB | |
| FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xsl | May 2, 2022 | 183 KB | |
| FDA CBER 2021 5683 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xml | May 2, 2022 | 985 KB | |
| FDA CBER 2021 5683 0058795 to 0058828_125742_S1_M5_bnt162 01 A define 2 0 0.xsl | May 2, 2022 | 183 KB | |
| FDA CBER 2021 5683 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xml | May 2, 2022 | 828 KB | |
| FDA CBER 2021 5683 0058653 to 0058675_125742_S1_M5_c4591001 S Supp define 2 0 0.xsl | May 2, 2022 | 183 KB | |
| FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xml | May 2, 2022 | 300 KB | |
| FDA CBER 2021 5683 0058595 to 0058614_125742_S1_M5_c4591001 S define 2 0 0.xsl | May 2, 2022 | 183 KB | |
| FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xml | May 2, 2022 | 904 KB | |
| FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xsl | May 2, 2022 | 183 KB | |
| FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xml | May 2, 2022 | 692 KB | |
| FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xpt | May 2, 2022 | 44 MB | |
| FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt) | May 2, 2022 | 79 MB | |
| FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt) | May 2, 2022 | 6 MB | |
| reissue_5.3.6 postmarketing experience.pdf | April 1, 2022 | 958 KB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdf | April 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf | April 1, 2022 | 28 MB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdf | April 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdf | April 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdf | April 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdf | April 1, 2022 | 5 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf | April 1, 2022 | 59 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-randomization.pdf | April 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-publications.pdf | April 1, 2022 | 10 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdf | April 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdf | April 1, 2022 | 677 KB | |
| 125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf | April 1, 2022 | 8 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-demographics.pdf | April 1, 2022 | 28 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdf | April 1, 2022 | 869 KB | |
| 125742_S1_M1_priority-review-request.pdf | March 24, 2022 | 2 MB | |
| 125742_S1_M1_priority-review-request.pdf | March 24, 2022 | 2 MB | |
| FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx | March 1, 2022 | 10 KB | |
| FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx | March 1, 2022 | 17 KB | |
| FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx | March 1, 2022 | 10 KB | |
| FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx | March 1, 2022 | 10 KB | |
| FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx | March 1, 2022 | 35 KB | |
| FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx | March 1, 2022 | 84 KB | |
| FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx | March 1, 2022 | 23 KB | |
| FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx | March 1, 2022 | 18 KB | |
| FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx | March 1, 2022 | 19 KB | |
| FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx | March 1, 2022 | 22 KB | |
| FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx | March 1, 2022 | 13 KB | |
| FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx | March 1, 2022 | 29 KB | |
| FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx | March 1, 2022 | 11 KB | |
| FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx | March 1, 2022 | 24 KB | |
| FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx | March 1, 2022 | 21 KB | |
| FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsx | March 1, 2022 | 14 KB | |
| FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsx | March 1, 2022 | 10 KB | |
| FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xsl | March 1, 2022 | 183 KB | |
| FDA-CBER-2021-5683-0023150 to -0023454_125742_S1_M5_c4591001-A-define.xml | March 1, 2022 | 1 MB | |
| FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt | March 1, 2022 | 197 KB | |
| FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txt | March 1, 2022 | 75 KB | |
| FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt | March 1, 2022 | 75 KB | |
| FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt | March 1, 2022 | 29 KB | |
| FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt | March 1, 2022 | 24 KB | |
| FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt | March 1, 2022 | 75 KB | |
| FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt | March 1, 2022 | 11 KB | |
| FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt | March 1, 2022 | 49 KB | |
| FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt | March 1, 2022 | 43 KB | |
| FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt | March 1, 2022 | 45 KB | |
| FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txt | March 1, 2022 | 72 KB | |
| FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txt | March 1, 2022 | 20 KB | |
| FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt | March 1, 2022 | 19 KB | |
| FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txt | March 1, 2022 | 18 KB | |
| FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txt | March 1, 2022 | 81 KB | |
| FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txt | March 1, 2022 | 15 KB | |
| FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txt | March 1, 2022 | 15 KB | |
| FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txt | March 1, 2022 | 35 KB | |
| FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt | March 1, 2022 | 14 KB | |
| FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txt | March 1, 2022 | 15 KB | |
| FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt | March 1, 2022 | 32 KB | |
| FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt | March 1, 2022 | 156 KB | |
| FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt | March 1, 2022 | 27 KB | |
| FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txt | March 1, 2022 | 193 KB | |
| 125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf | March 1, 2022 | 629 KB | |
| 125742_S1_M5_c4591001-A-report-cci-renal.pdf | March 1, 2022 | 629 KB | |
| 125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf | March 1, 2022 | 630 KB | |
| 125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf | March 1, 2022 | 632 KB | |
| 125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf | March 1, 2022 | 625 KB | |
| 125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf | March 1, 2022 | 626 KB | |
| 125742_S1_M5_CRF_c4591001-1085-10851246.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001-1085-10851216.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001-1085-10851129.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001-1085-10851116.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001-1085-10851018.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf | March 1, 2022 | 17 MB | |
| 125742_S1_M5_c4591001-T-S-suppl-arg.pdf | March 1, 2022 | 738 KB | |
| 125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf | March 1, 2022 | 667 KB | |
| 125742_S1_M5_c4591001-T-S-roadmap.pdf | March 1, 2022 | 703 KB | |
| 125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf | March 1, 2022 | 627 KB | |
| 125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf | March 1, 2022 | 626 KB | |
| 125742_S1_M5_c4591001-A-report-cci-dementia.pdf | March 1, 2022 | 626 KB | |
| 125742_S1_M5_c4591001-A-report-cci-chf.pdf | March 1, 2022 | 628 KB | |
| 125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf | March 1, 2022 | 632 KB | |
| 125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf | March 1, 2022 | 670 KB | |
| 125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf | March 1, 2022 | 629 KB | |
| 125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf | March 1, 2022 | 846 KB | |
| 125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf | March 1, 2022 | 607 KB | |
| 125742_S1_M5_c4591001-A-comorbidity-categories.pdf | March 1, 2022 | 637 KB | |
| 125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf | March 1, 2022 | 620 KB | |
| 125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf | March 1, 2022 | 634 KB | |
| 125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf | March 1, 2022 | 628 KB | |
| 125742_S1_M5_c4591001-A-report-cci-mi.pdf | March 1, 2022 | 624 KB | |
| 125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf | March 1, 2022 | 636 KB | |
| 125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf | March 1, 2022 | 640 KB | |
| 125742_S1_M5_c4591001-A-report-cci-leukemia.pdf | March 1, 2022 | 631 KB | |
| 125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf | March 1, 2022 | 626 KB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf | March 1, 2022 | 37 MB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf | March 1, 2022 | 13 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf | March 1, 2022 | 31 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf | March 1, 2022 | 5 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdf | March 1, 2022 | 12 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf | March 1, 2022 | 16 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-errata.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-compliance.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf | March 1, 2022 | 889 KB | |
| 125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf | March 1, 2022 | 627 KB | |
| 125742_S1_M5_c4591001-A-adrg.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf | March 1, 2022 | 602 KB | |
| 125742_S1_M1_us-agent-authorization.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M1_trans-of-oblig.pdf | March 1, 2022 | 717 KB | |
| 125742_S1_M1_ipsp-agreed-letter.pdf | March 1, 2022 | 658 KB | |
| 125742_S1_M1_financial-cert-bias.pdf | March 1, 2022 | 696 KB | |
| 125742_S1_M1_financial-cert-3454.pdf | March 1, 2022 | 3 MB | |
| 125742_S1_M1_fast-track-designation.pdf | March 1, 2022 | 649 KB | |
| 125742_S1_M1_exclusivity-claim.pdf | March 1, 2022 | 616 KB | |
| 125742_S1_M1_debarment.pdf | March 1, 2022 | 656 KB | |
| 125742_S1_M1_cover.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M1_3674.pdf | March 1, 2022 | 5 MB | |
| 125742_S1_M1_356h.pdf | March 1, 2022 | 714 KB | |
| 125742_S1_M4_4223_R-20-0072.pdf | March 1, 2022 | 5 MB | |
| 125742_S1_M4_4223_185350.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M2_27_synopses-indiv-studies.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M2_27_literature-references.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M2_26_pharmkin-written-summary.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M2_26_pharmkin-tabulated-summary.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M2_24_nonclinical-overview.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M2_22_introduction.pdf | March 1, 2022 | 670 KB | |
| 125742_S1_M1_waiver-req-designated-suffix.pdf | March 1, 2022 | 3 MB | |
| 125742_S1_M1_userfee.pdf | March 1, 2022 | 628 KB | |
| CRFs-for-site-1128.pdf | January 31, 2022 | 14 MB | |
| CRFs-for-site-1096.pdf | January 18, 2022 | 11 MB | |
| CRFs-for-site-1081.pdf | December 30, 2021 | 13 MB | |
| Supplemental-Index-12-22-21.pdf | December 22, 2021 | 2 MB | |
| STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdf | December 13, 2021 | 6 MB | |
| STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf | December 13, 2021 | 3 MB | |
| STN-125742_0_0-Section-2.5-Clinical-Overview.pdf | December 13, 2021 | 4 MB | |
| signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf | December 13, 2021 | 207 KB | |
| CRFs-for-site-1055.pdf | December 13, 2021 | 6 MB | |
| BATES-FDA-CBER-2021-5683-0002379_te.xpt | December 13, 2021 | 3 KB | |
| BATES-FDA-CBER-2021-5683-0002380_ti.xpt | December 13, 2021 | 37 KB | |
| BATES-FDA-CBER-2021-5683-0002377_supppr.xpt | December 13, 2021 | 72 KB | |
| BATES-FDA-CBER-2021-5683-0002378_ta.xpt | December 13, 2021 | 8 KB | |
| BATES-FDA-CBER-2021-5683-0002376_relrec.xpt | December 13, 2021 | 567 KB | |
| BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt | December 13, 2021 | 5 KB | |
| BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt | December 13, 2021 | 9 KB | |
| BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt | December 13, 2021 | 9 KB | |
| BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt | December 13, 2021 | 9 KB | |
| Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdf | December 1, 2021 | 14 MB | |
| Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdf | December 1, 2021 | 12 MB | |
| BATES-93_tv.xpt | November 17, 2021 | 16 KB | |
| 5.2-tabular-listing.pdf | November 17, 2021 | 2 MB | |
| 5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf | November 17, 2021 | 8 MB | |
| BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txt | November 17, 2021 | 9 KB | |
| 5.3.6-postmarketing-experience.pdf | November 17, 2021 | 984 KB | |
