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File NameTypeDate ProducedSizeLinkhf:file_type
125752_S3_M5_CRF_mrna 1273 p301 us3632154pdfMay 22, 2025594 KBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3632127pdfMay 22, 2025594 KBpdf
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125752_S3_M5_CRF_mrna 1273 p301 us3632022pdfMay 22, 2025594 KBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3222611pdfMay 22, 20256 MBpdf
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125752_S3_M5_CRF_mrna 1273 p301 us3812060pdfMay 22, 2025596 KBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3812059pdfMay 22, 2025596 KBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3812010pdfMay 22, 2025596 KBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3222388pdfMay 22, 20255 MBpdf
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125752_S3_M5_CRF_mrna 1273 p301 us3222089pdfMay 22, 20257 MBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3222077pdfMay 22, 20257 MBpdf
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125752_S3_M5_CRF_mrna 1273 p301 us3222032pdfMay 22, 20255 MBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3222017pdfMay 22, 20254 MBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3222013pdfMay 22, 20255 MBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3222004pdfMay 22, 20256 MBpdf
125752_S3_M5_bimo_D_define2 0 0pdfMay 22, 2025808 KBpdf
125752_S3_M5_bimo_D_definepdfMay 22, 2025602 KBpdf
125752_S3_M2_23_qos introductionpdfMay 22, 2025858 KBpdf
125752_S3_M2_23_qos appendicespdfMay 22, 2025868 KBpdf
125752_S3_M1_request for a waiver 1pdfMay 22, 2025587 KBpdf
125752_S3_M1_form 356h 0003pdfMay 22, 20254 MBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3222422pdfMay 22, 20257 MBpdf
125752_S2_M3_32s44_coa 1054 mrna cx 024414 lot 4007421022pdfMay 22, 20251 MBpdf
125752_S2_M3_32s44_coa 1051 cx 024414 mrna lot 4007421008pdfMay 22, 20252 MBpdf
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125752_S2_M3_32s44_coa 1002 cx 024414 mrna lot 4007421006pdfMay 22, 20252 MBpdf
125752_S2_M3_32s44_coa 0987 lot 5007521010pdfMay 22, 20253 MBpdf
125752_S2_M3_32s44_coa 0977 cx 024414 mrna lot 4007421005pdfMay 22, 20252 MBpdf
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125752_S2_M3_32s44_coa 0866 lot 5007521020pdfMay 22, 20251 MBpdf
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125752_S2_M3_32s44_coa 0736 cx 024414 mrna lot 4007420016pdfMay 22, 2025620 KBpdf
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125752_S2_M3_32s44_coa 0627 cx 024414 mrna lot 4007420010pdfMay 22, 2025622 KBpdf
125752_S2_M3_32s44_coa 0604 lot 5007520502pdfMay 22, 20251 MBpdf
125752_S2_M3_32s44_coa 0594 cx 024414 ds lot 4007420006pdfMay 22, 2025622 KBpdf
125752_S2_M3_32s44_coa 1321 cx 024414 mrna lot 4007921005pdfMay 22, 2025663 KBpdf
125752_S2_M3_32s44_coa 1320 cx 024414 mrna lot 4007921003pdfMay 22, 2025664 KBpdf
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125752_S2_M3_32s44_coa 0573 cx 024414 ds lot 4007420004pdfMay 22, 2025621 KBpdf
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125752_S2_M3_32s44_coa 0549 mrna cx 024414 lot 4007420003pdfMay 22, 2025785 KBpdf
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125752_S2_M3_32s44_coa 0459 lot 5006820004pdfMay 22, 20251 MBpdf
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125752_S2_M3_32s44_coa 0453 cx 024414 ds lot 4007220004pdfMay 22, 2025620 KBpdf
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125752_S2_M3_32s44_coa 0434 lot 5006820002pdfMay 22, 2025630 KBpdf
125752_S2_M3_32s44_coa 0430 cx 024414 ds lot 4007220002pdfMay 22, 20252 MBpdf
125752_S2_M3_32s44_coa 0393 mrna 1273 dp lot 8520100104pdfMay 22, 2025624 KBpdf
125752_S2_M3_32s44_coa 0387 mrna 1273 dp lot 8520100103pdfMay 22, 2025624 KBpdf
125752_S2_M3_32s44_coa 0386 mrna 1273 dp lot 8520100102pdfMay 22, 2025624 KBpdf
125752_S2_M3_32s44_coa 0363 mrna 1273 dp lot 8520100101pdfMay 22, 202516 MBpdf
125752_S2_M3_32s43_val of analyt proc mrna 1273 lnppdfMay 22, 2025655 KBpdf
125752_S2_M3_32s44_coa 0591 lot 5007520009pdfMay 22, 20251 MBpdf
125752_S2_M3_32s44_coa 0590 lot 5007520004pdfMay 22, 20251 MBpdf
125752_S2_M3_32s42_analytical procedures mrna 1273 lnppdfMay 22, 2025689 KBpdf
125752_S2_M3_32s42_analytical procedures_cx 024414 allpdfMay 22, 2025689 KBpdf
125752_S2_M3_32s41_specification_mrna 1273 lnp allpdfMay 22, 2025662 KBpdf
125752_S2_M3_32s41_specification_cx 024414 allpdfMay 22, 2025655 KBpdf
125752_S2_M3_32s5_coa 0927 lot d006520001pdfMay 22, 2025685 KBpdf
125752_S2_M3_32s2_manufacturer_mrna 1273 lnp allpdfMay 22, 20251 MBpdf
125752_S2_M3_32s1_nomenclature_mrna 1273 lnp allpdfMay 22, 2025702 KBpdf
125752_S2_M3_32s1_nomenclature_cx 024414 allpdfMay 22, 2025673 KBpdf
125752_S2_M3_32p54_cofa 0393 dp lot 8520100104pdfMay 22, 20251 MBpdf
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125752_S2_M3_32s43_validation analyt procedurepdfMay 22, 2025654 KBpdf
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125752_S2_M3_32p54_batch analysespdfMay 22, 20251 MBpdf
125752_S2_M3_32p53_val anal proc phpdfMay 22, 2025686 KBpdf
125752_S2_M3_32p53_val anal proc particulate matterpdfMay 22, 2025685 KBpdf
125752_S2_M3_32p53_val anal proc osmolalitypdfMay 22, 2025685 KBpdf
125752_S2_M3_32p53_val anal proc appearancepdfMay 22, 2025748 KBpdf
125752_S2_M3_32p52_analytical procedures bacterial endotoxinspdfMay 22, 2025680 KBpdf
125752_S2_M3_32p54_coa 0615 6007320012 011l20pdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_stability summarypdfMay 22, 2025967 KBpdf
125752_S2_M3_32p8_stability datapdfMay 22, 2025754 KBpdf
125752_S2_M3_32p8_postapproval stabilitypdfMay 22, 2025676 KBpdf
125752_S2_M3_32p8_modeling stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_freezethaw stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6008620007 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6008620002 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6008620001 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6008520001 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007920003 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007920002 stability reportpdfMay 22, 20251 MBpdf
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125752_S2_M3_32p8_6007520004 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007520003 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007520002 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007520001 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007320012 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007320010 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007320009 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007320008 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p8_6007320005 stability reportpdfMay 22, 20251 MBpdf
125752_S2_M3_32p52_analytical procedurespdfMay 22, 2025692 KBpdf
125752_S2_M3_32p51_specificationspdfMay 22, 2025670 KBpdf
125752_S2_M3_32p1_description and compositionpdfMay 22, 2025709 KBpdf
125752_S2_M3_32a3_excipient informationpdfMay 22, 2025638 KBpdf
125752_S2_M3_32a2_adventitious agents reportpdfMay 22, 2025642 KBpdf
125752_S2_M1_form 356h 0002pdfMay 22, 20254 MBpdf
125752_S2_M1_cover 0002pdfMay 22, 20251 MBpdf
112_BLA 125752 0_01 31 2022_Memo_OtherpdfMay 22, 2025682 KBpdf
107_BLA 125752 0_01 31 2022_Inspection Related_InspectpdfMay 22, 20251 MBpdf
105A_BLA 125752 0_01 28 2022_Telecon_Information RequespdfMay 22, 20252 MBpdf
105_BLA 125752 0_01 28 2022_Telecon_Information RequespdfMay 22, 2025671 KBpdf
103D_BLA 125752 0_01 28 2022_Memo_Request For CompliancpdfMay 22, 2025659 KBpdf
103A_BLA 125752 0_01 28 2022_Memo_Request For CompliancpdfMay 22, 2025669 KBpdf
103_BLA 125752 0_01 28 2022_Memo_Request For CompliancpdfMay 22, 2025681 KBpdf
102D_BLA 125752 0_01 28 2022_Memo_Compliance Check AccepdfMay 22, 2025659 KBpdf
102A_BLA 125752 0_01 28 2022_Memo_Compliance Check AccepdfMay 22, 2025669 KBpdf
102_BLA 125752 0_01 28 2022_Memo_Compliance Check AccepdfMay 22, 2025759 KBpdf
95_BLA 125752 0_01 26 2022_Telecon_Information RequespdfMay 22, 2025640 KBpdf
125752_S2_M3_32p6_reference standardspdfMay 22, 2025621 KBpdf
125752_S2_M3_32p4_novel excipientspdfMay 22, 2025621 KBpdf
125752_S2_M3_32p4_excipients human animalpdfMay 22, 2025623 KBpdf
125752_S2_M3_32p3_manufacturerspdfMay 22, 2025625 KBpdf
78C_BLA 125752 0_01 11 2022_Memo_Committee Memo_ReviewpdfMay 22, 2025670 KBpdf
78B_BLA 125752 0_01 11 2022_Memo_Committee Memo_ReviewpdfMay 22, 2025680 KBpdf
78A_BLA 125752 0_01 11 2022_Memo_Committee Memo_ReviewpdfMay 22, 2025820 KBpdf
78_BLA 125752 0_01 11 2022_Memo_Committee Memo_ReviewpdfMay 22, 2025890 KBpdf
77_BLA 125752 0_01 10 2022_Memo_Committee Memo_APLBpdfMay 22, 2025752 KBpdf
76_BLA 125752 0_01 07 2022_Telecon_Information RequespdfMay 22, 2025643 KBpdf
75_BLA 125752 0_01 05 2022_Memo_Lot Release ClearancepdfMay 22, 2025731 KBpdf
74_BLA 125752 0_01 05 2022_Memo_Committee Memo_LabelipdfMay 22, 2025803 KBpdf
94_BLA 125752 0_01 26 2022_Memo_OtherpdfMay 22, 2025623 KBpdf
93_BLA 125752 0_01 26 2022_Inspection Related_InspectpdfMay 22, 2025936 KBpdf
92_BLA 125752 0_01 24 2022_Telecon_Information RequespdfMay 22, 2025591 KBpdf
90_BLA 125752 0_01 20 2022_Telecon_OtherpdfMay 22, 2025667 KBpdf
89_BLA 125752 0_01 20 2022_Memo_Committee Memo_ReviewpdfMay 22, 2025592 KBpdf
87_BLA 125752 0_01 18 2022_Memo_Test ResultspdfMay 22, 2025760 KBpdf
85_BLA 125752 0_01 14 2022_Telecon_Information RequespdfMay 22, 2025651 KBpdf
84_BLA 125752 0_01 13 2022_Telecon_Information RequespdfMay 22, 2025645 KBpdf
80_BLA 125752 0_01 12 2022_Telecon_Information RequespdfMay 22, 2025711 KBpdf
79_BLA 125752 0_01 11 2022_Telecon_AdvicepdfMay 22, 2025644 KBpdf
78G_BLA 125752 0_01 11 2022_Memo_Committee Memo_ReviewpdfMay 22, 20254 MBpdf
78F_BLA 125752 0_01 11 2022_Memo_Committee Memo_ReviewpdfMay 22, 20251 MBpdf
78E_BLA 125752 0_01 11 2022_Memo_Committee Memo_ReviewpdfMay 22, 20256 MBpdf
78D_BLA 125752 0_01 11 2022_Memo_Committee Memo_ReviewpdfMay 22, 2025679 KBpdf
70_BLA 125752 0_12 28 2021_Inspection Related_InspectpdfMay 22, 2025669 KBpdf
69B_BLA 125752 0_12 23 2021_Telecon_Information RequespdfMay 22, 2025919 KBpdf
69A_BLA 125752 0_12 23 2021_Telecon_Information RequespdfMay 22, 2025918 KBpdf
68_BLA 125752 0_12 23 2021_Telecon_Information RequespdfMay 22, 2025648 KBpdf
67_BLA 125752 0_12 23 2021_Telecon_Information RequespdfMay 22, 2025591 KBpdf
66_BLA 125752 0_12 21 2021_Telecon_Information RequespdfMay 22, 2025708 KBpdf
65_BLA 125752 0_12 17 2021_Telecon_Information RequespdfMay 22, 2025648 KBpdf
64_BLA 125752 0_12 16 2021_Telecon_Information RequespdfMay 22, 2025646 KBpdf
63_BLA 125752 0_12 16 2021_Telecon_Information RequespdfMay 22, 2025718 KBpdf
62_BLA 125752 0_12 16 2021_Telecon_Information RequespdfMay 22, 2025664 KBpdf
61_BLA 125752 0_12 16 2021_Telecon_Information RequespdfMay 22, 2025648 KBpdf
59_BLA 125752 0_12 15 2021_Telecon_AdvicepdfMay 22, 2025768 KBpdf
57A_BLA 125752 0_12 14 2021_Telecon_Information RequespdfMay 22, 2025655 KBpdf
57_BLA 125752 0_12 14 2021_Telecon_Information RequespdfMay 22, 2025773 KBpdf
56_BLA 125752 0_12 10 2021_Telecon_Information RequespdfMay 22, 2025643 KBpdf
55_BLA 125752 0_12 10 2021_Telecon_Information RequespdfMay 22, 2025662 KBpdf
54A_BLA 125752 0_12 10 2021_Telecon_Information RequespdfMay 22, 20251 MBpdf
54_BLA 125752 0_12 10 2021_Telecon_Information RequespdfMay 22, 2025678 KBpdf
53_BLA 125752 0_12 10 2021_Telecon_Information RequespdfMay 22, 2025644 KBpdf
52_BLA 125752 0_12 09 2021_Telecon_Information RequespdfMay 22, 2025675 KBpdf
73_BLA 125752 0_01 04 2022_Memo_Test ResultspdfMay 22, 2025724 KBpdf
72_BLA 125752 0_01 03 2022_Memo_Committee Memo_APLBpdfMay 22, 2025752 KBpdf
30_BLA 125752 0_10 29 2021_Telecon_OtherpdfMay 22, 20258 MBpdf
51_BLA 125752 0_12 09 2021_Telecon_AdvicepdfMay 22, 2025894 KBpdf
50_BLA 125752 0_12 07 2021_Telecon_Information RequespdfMay 22, 2025707 KBpdf
49_BLA 125752 0_12 06 2021_Telecon_Information RequespdfMay 22, 2025691 KBpdf
48A_BLA 125752 0_12 06 2021_Telecon_Information RequespdfMay 22, 2025966 KBpdf
48_BLA 125752 0_12 06 2021_Telecon_Information RequespdfMay 22, 2025623 KBpdf
47_BLA 125752 0_12 01 2021_Telecon_Information RequespdfMay 22, 2025645 KBpdf
46_BLA 125752 0_11 29 2021_Telecon_Information RequespdfMay 22, 2025721 KBpdf
45_BLA 125752 0_11 29 2021_Telecon_Information RequespdfMay 22, 2025647 KBpdf
44_BLA 125752 0_11 24 2021_Telecon_OtherpdfMay 22, 2025726 KBpdf
43_BLA 125752 0_11 19 2021_Telecon_Information RequespdfMay 22, 2025649 KBpdf
42_BLA 125752 0_11 19 2021_Telecon_AdvicepdfMay 22, 2025684 KBpdf
40B_BLA 125752 0_11 15 2021_Telecon_Information RequespdfMay 22, 20251 MBpdf
40A_BLA 125752 0_11 15 2021_Telecon_Information RequespdfMay 22, 20251 MBpdf
40_BLA 125752 0_11 15 2021_Telecon_Information RequespdfMay 22, 20252 MBpdf
39_BLA 125752 0_11 12 2021_Telecon_Information RequespdfMay 22, 2025682 KBpdf
38_BLA 125752 0_11 10 2021_Telecon_Information RequespdfMay 22, 2025645 KBpdf
37_BLA 125752 0_11 10 2021_Telecon_Information RequespdfMay 22, 2025722 KBpdf
36_BLA 125752 0_11 05 2021_Telecon_Information RequespdfMay 22, 2025590 KBpdf
35_BLA 125752 0_11 05 2021_Telecon_Information RequespdfMay 22, 2025665 KBpdf
34_BLA 125752 0_11 03 2021_Telecon_OtherpdfMay 22, 2025637 KBpdf
33_BLA 125752 0_11 03 2021_Telecon_Information RequespdfMay 22, 2025651 KBpdf
32_BLA 125752 0_11 01 2021_Telecon_Information RequespdfMay 22, 2025597 KBpdf
31_BLA 125752 0_11 01 2021_Telecon_Information RequespdfMay 22, 2025728 KBpdf
30D_BLA 125752 0_10 29 2021_Telecon_OtherpdfMay 22, 2025753 KBpdf
30C_BLA 125752 0_10 29 2021_Telecon_OtherpdfMay 22, 2025753 KBpdf
30B_BLA 125752 0_10 29 2021_Telecon_OtherpdfMay 22, 20251 MBpdf
30A_BLA 125752 0_10 29 2021_Telecon_OtherpdfMay 22, 20251 MBpdf
26_BLA 125752 0_10 22 2021_Telecon_Information RequespdfMay 22, 2025823 KBpdf
25_BLA 125752 0_10 21 2021_Telecon_Information RequespdfMay 22, 2025709 KBpdf
24_BLA 125752 0_10 20 2021_Telecon_Information RequespdfMay 22, 2025708 KBpdf
22_BLA 125752 0_10 15 2021_Letter_PNR AcceptancepdfMay 22, 2025651 KBpdf
21A_BLA 125752 0_10 14 2021_Telecon_OtherpdfMay 22, 2025933 KBpdf
21_BLA 125752 0_10 14 2021_Telecon_OtherpdfMay 22, 2025637 KBpdf
20_BLA 125752 0_10 14 2021_Telecon_Information RequespdfMay 22, 2025646 KBpdf
19_BLA 125752 0_10 14 2021_Letter_Filing NotificationpdfMay 22, 2025653 KBpdf
18_BLA 125752 0_10 06 2021_Telecon_Information RequespdfMay 22, 2025658 KBpdf
17_BLA 125752 0_10 05 2021_Telecon_Information RequespdfMay 22, 2025668 KBpdf
16_BLA 125752 0_09 30 2021_Memo_OtherpdfMay 22, 2025792 KBpdf
15_BLA 125752 0_09 28 2021_Telecon_Information RequespdfMay 22, 2025726 KBpdf
13_BLA 125752 0_09 27 2021_Telecon_OtherpdfMay 22, 20252 MBpdf
12_BLA 125752 0_09 27 2021_Telecon_AdvicepdfMay 22, 20251,020 KBpdf
11_BLA 125752 0_09 27 2021_Memo_Committee Memo_APLBpdfMay 22, 2025773 KBpdf
10_BLA 125752 0_09 24 2021_Telecon_Information RequespdfMay 22, 2025771 KBpdf
9_BLA 125752 0_09 23 2021_Telecon_Information RequespdfMay 22, 2025591 KBpdf
8_BLA 125752 0_09 23 2021_Telecon_AdvicepdfMay 22, 2025620 KBpdf
7_BLA 125752 0_09 22 2021_Telecon_Information RequespdfMay 22, 2025651 KBpdf
6_BLA 125752 0_09 21 2021_Telecon_AdvicepdfMay 22, 2025650 KBpdf
5_BLA 125752 0_09 17 2021_Telecon_Information RequespdfMay 22, 2025796 KBpdf
4_BLA 125752 0_09 14 2021_Telecon_Information RequespdfMay 22, 2025657 KBpdf
3_BLA 125752 0_09 09 2021_Meeting Summary_CommitteepdfMay 22, 2025802 KBpdf
2A_BLA 125752 0_08 20 2021_Telecon_Information Reques_pdfMay 22, 20251,009 KBpdf
2_BLA 125752 0_08 20 2021_Telecon_Information RequespdfMay 22, 2025577 KBpdf
1_BLA 125752 0_06 09 2021_Letter_Acknowledgement LetpdfMay 22, 2025648 KBpdf
28_BLA 125752 0_10 26 2021_Telecon_Information RequespdfMay 22, 2025736 KBpdf
27_BLA 125752 0_10 22 2021_Telecon_Information RequespdfMay 22, 2025666 KBpdf
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125752_S49_M1_form 356h 0049pdfJanuary 2, 20244 MBpdf
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125752_S1_M4.3_meyer 2007.pdfpdfSeptember 1, 2023688 KBpdf
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