Dossier DOS-022

Dossier in NeeS format, version 1.4.5, for application EMA-2023-0022. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-022
Format
NeeS
Version
1.4.5
Status
Active
Application
EMA-2023-0022
Created
2022-11-23
Updated
2024-04-18
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information6Active
2CTD Summaries5Blocked
3Quality8Submitted
4Nonclinical Study Reports15Draft
5Clinical Study Reports5Completed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0225.1.4Integrated Summary of Safety7.2Word5,846DraftPriya Sharma
CC-1225.3.1Study Reports – Efficacy3.3HTML1,560DraftSarah Chen
CC-2221.2.8Application Form4.0HTML10,322BlockedMarcus Webb
CC-3225.1.9Study Reports – Clinical Pharmacology10.1HTML5,346PendingLieselotte van der Berg
CC-4225.1.7Study Reports – Efficacy11.7Word4,039ApprovedNadia Petrova
CC-5224.5.9Genotoxicity8.8Word3,395FailedSarah Chen
CC-6224.6.6Pharmacology Studies1.8Word4,684CompletedTomoko Ikeda
CC-7223.4.8Stability Data8.6XML14,782DraftDmitri Volkov
CC-8225.8.7Study Reports – Safety11.4HTML2,826DraftAisha Okonkwo
CC-9224.7.4Pharmacokinetics Studies10.0PDF6,752ActiveTomoko Ikeda
CC-10222.2.9Clinical Summary7.9HTML4,459DraftCarlos Mendez
CC-11222.2.8Nonclinical Overview2.4XML3,420PendingSarah Chen
CC-12223.8.2Appendices2.3PDF8,281BlockedLieselotte van der Berg
CC-13222.1.4Quality Overall Summary3.9XML3,977FailedSarah Chen
CC-14225.3.6Study Reports – Clinical Pharmacology5.8XML634SubmittedDmitri Volkov
CC-15223.3.5Analytical Methods1.1Word8,410BlockedAisha Okonkwo
CC-16225.2.6Integrated Summary of Efficacy9.0PDF4,182In ProgressDmitri Volkov
CC-17224.7.5Pharmacology Studies12.3PDF11,704BlockedMarcus Webb
CC-18225.1.2Integrated Summary of Efficacy4.8XML12,385FailedLieselotte van der Berg
CC-19222.1.6Nonclinical Overview8.2PDF11,243PendingSarah Chen