Dossier DOS-042

Dossier in eCTD format, version 8.9.5, for application EMA-2023-0042. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-042
Format
eCTD
Version
8.9.5
Status
Blocked
Application
EMA-2023-0042
Created
2022-01-21
Updated
2023-06-28
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information15Overdue
2CTD Summaries13In Progress
3Quality14Approved
4Nonclinical Study Reports10Failed
5Clinical Study Reports7Failed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0422.8.3Nonclinical Summary5.4Word7,190PendingLieselotte van der Berg
CC-1424.9.3Genotoxicity7.7XML12,298In ProgressDmitri Volkov
CC-2423.7.6Appendices8.1PDF10,760PendingAisha Okonkwo
CC-3424.2.1Pharmacokinetics Studies11.9PDF14,107FailedMarcus Webb
CC-4422.2.7Quality Overall Summary1.4Word1,327ApprovedSarah Chen
CC-5423.6.2Appendices11.3PDF7,130CompletedLieselotte van der Berg
CC-6423.1.7Stability Data9.0PDF5,303In ProgressLieselotte van der Berg
CC-7423.2.2Appendices1.8Word8,769PendingPriya Sharma
CC-8425.9.6Study Reports – Clinical Pharmacology4.7PDF13,961BlockedSarah Chen
CC-9423.8.1Drug Product12.4XML13,678SubmittedDmitri Volkov
CC-10424.1.9Carcinogenicity6.8PDF12,020In ProgressPriya Sharma
CC-11424.9.7Carcinogenicity9.2XML5,951BlockedMarcus Webb
CC-12424.2.5Pharmacology Studies11.9Word3,941FailedPriya Sharma
CC-13424.9.1Toxicology Studies11.9Word7,048FailedNadia Petrova
CC-14423.2.6Container Closure System11.4HTML6,829FailedLieselotte van der Berg
CC-15422.1.7Clinical Summary7.5XML12,828CompletedJames O'Brien
CC-16423.8.9Analytical Methods5.1PDF8,285DraftAisha Okonkwo
CC-17425.1.2Study Reports – Efficacy11.0XML1,608FailedLieselotte van der Berg
CC-18424.6.8Pharmacology Studies10.3HTML13,251OverdueAisha Okonkwo
CC-19423.2.1Container Closure System6.7Word14,461SubmittedMarcus Webb