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EMA_VR_0000300518
大小 20.39 MB
文件数 47
Info Hash: 912BAC90804641C24B1C247BD51E0739D72D61AB
收录时间 2026-01-16 18:07:43
更新时间 2026-01-16 18:07:43
文件列表 (47)
0061_4/index.xml
7.59 KB
0061_4/index-md5.txt
32 B
0061_4/m1/eu/10-cover/common/common-cover-letter.pdf
116.53 KB
0061_4/m1/eu/10-cover/lt/lt-tracking-table.pdf
211.26 KB
0061_4/m1/eu/12-form/common/common-form-annex-adventitious-agents.pdf
648.17 KB
0061_4/m1/eu/12-form/common/common-form-annex-a-hexacima.pdf
89.85 KB
0061_4/m1/eu/12-form/common/common-form-annex-a-hexyon.pdf
91.44 KB
0061_4/m1/eu/12-form/common/common-form-annex-amend-doc.pdf
338.94 KB
0061_4/m1/eu/12-form/common/common-form-annex-b.pdf
125.17 KB
0061_4/m1/eu/12-form/common/common-form-annex-control-biological-origin.pdf
226.75 KB
0061_4/m1/eu/12-form/common/common-form-annex-control-cell-bank.pdf
546.36 KB
0061_4/m1/eu/12-form/common/common-form-annex-impurities.pdf
1.09 MB
0061_4/m1/eu/12-form/common/common-form-annex-list-controls.pdf
270.43 KB
0061_4/m1/eu/12-form/common/common-form-annex-manuf-process.pdf
2.4 MB
0061_4/m1/eu/12-form/common/common-form-annex-process-validation.pdf
2.03 MB
0061_4/m1/eu/12-form/common/common-form-annex-table-a.pdf
275.91 KB
0061_4/m1/eu/12-form/common/common-form-eaf.pdf
884.79 KB
0061_4/m1/eu/12-form/lt/lt-form-annex-pop.pdf
480.8 KB
0061_4/m1/eu/14-expert/141-quality/quality-signature-richoux.pdf
227.69 KB
0061_4/m1/eu/eu-regional.xml
7.67 KB
0061_4/m2/23-qos/appendices.pdf
173.91 KB
0061_4/m2/23-qos/drug-substance-characterisation.pdf
432.24 KB
0061_4/m2/23-qos/drug-substance-manufacture.pdf
1.3 MB
0061_4/m3/32-body-data/32a-app/32a2-advent-agent/sanofi-pasteur/adventitious-agents-report-ipv.pdf
254.53 KB
0061_4/m3/32-body-data/32r-reg-info/reg-info-rev-6.pdf
226.59 KB
0061_4/m3/32-body-data/32r-reg-info/reg-info-table-a.pdf
169.76 KB
0061_4/m3/32-body-data/32s-drug-sub/inactivated-vero-trivalent-poliovaccine-bulk-sanofi-pasteur/32s2-manuf/control-of-materials-biological.pdf
177.03 KB
0061_4/m3/32-body-data/32s-drug-sub/inactivated-vero-trivalent-poliovaccine-bulk-sanofi-pasteur/32s2-manuf/control-of-materials-cell-bank-system.pdf
522.2 KB
0061_4/m3/32-body-data/32s-drug-sub/inactivated-vero-trivalent-poliovaccine-bulk-sanofi-pasteur/32s2-manuf/control-of-materials-list.pdf
242.86 KB
0061_4/m3/32-body-data/32s-drug-sub/inactivated-vero-trivalent-poliovaccine-bulk-sanofi-pasteur/32s2-manuf/manuf-process-development-working-cell-banks.pdf
1.9 MB
0061_4/m3/32-body-data/32s-drug-sub/inactivated-vero-trivalent-poliovaccine-bulk-sanofi-pasteur/32s2-manuf/process-validation-criticality.pdf
1.91 MB
0061_4/m3/32-body-data/32s-drug-sub/inactivated-vero-trivalent-poliovaccine-bulk-sanofi-pasteur/32s3-charac/impurities.pdf
621.05 KB
0061_4/util/dtd/eu-envelope.mod
3.39 KB
0061_4/util/dtd/eu-leaf.mod
2.16 KB
0061_4/util/dtd/eu-regional.dtd
4.78 KB
0061_4/util/dtd/ich-ectd-3-2.dtd
30.66 KB
0061_4/util/style/ectd-2-0.xsl
2 KB
0061_4/util/style/eu-regional.xsl
25.04 KB
0061_4-workingdocuments/1.0 Cover Letter.docx
71.78 KB
0061_4-workingdocuments/1.2 Annex - Amendment Document.docx
151.61 KB
0061_4-workingdocuments/1.2 Annex A - Hexacima.docx
20.21 KB
0061_4-workingdocuments/1.2 Annex A -Hexyon.docx
25.14 KB
0061_4-workingdocuments/1.2 Annex B.docx
64.69 KB
0061_4-workingdocuments/2.3.A.2 Adventitious Agents Safety Evaluation.doc
242.5 KB
0061_4-workingdocuments/2.3.S.2 Manufacture - MLE+VDR.docx
1.37 MB
0061_4-workingdocuments/2.3.S.3 Characterisation.doc
545 KB
0061_4-workingdocuments/Validation Checklist for Type II Quality Variations.docx
45.02 KB

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