Dossier DOS-082

Dossier in NeeS format, version 7.2.1, for application EMA-2023-0082. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-082
Format
NeeS
Version
7.2.1
Status
Failed
Application
EMA-2023-0082
Created
2022-01-24
Updated
2024-05-05
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information9Completed
2CTD Summaries14Failed
3Quality14Failed
4Nonclinical Study Reports6Completed
5Clinical Study Reports10Draft
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0823.4.4Stability Data3.8PDF9,063SubmittedNadia Petrova
CC-1822.7.4Clinical Overview7.1PDF2,285FailedSarah Chen
CC-2821.6.5Proposed Conditions of Approval1.5XML9,635In ProgressSarah Chen
CC-3822.6.1Quality Overall Summary10.3HTML2,920ApprovedTomoko Ikeda
CC-4823.6.8Manufacturing Process6.8PDF8,664DraftNadia Petrova
CC-5821.6.4Cover Letter9.5Word3,334In ProgressJames O'Brien
CC-6821.6.5Patient Labeling5.6HTML6,386BlockedLieselotte van der Berg
CC-7822.7.9Nonclinical Summary4.4Word9,225In ProgressCarlos Mendez
CC-8823.9.7Stability Data5.2Word9,914In ProgressNadia Petrova
CC-9824.4.8Pharmacology Studies6.0XML3,619DraftAisha Okonkwo
CC-10824.9.3Pharmacokinetics Studies3.2PDF11,897PendingDmitri Volkov
CC-11822.7.9Clinical Overview10.7XML3,124ApprovedLieselotte van der Berg
CC-12821.7.5Prescribing Information5.4Word612CompletedNadia Petrova
CC-13823.4.7Drug Product1.6Word13,695BlockedLieselotte van der Berg
CC-14825.3.8Integrated Summary of Safety7.5HTML12,807SubmittedSarah Chen
CC-15821.4.6Cover Letter7.3Word12,673PendingDmitri Volkov
CC-16825.3.8Study Reports – Safety6.9HTML9,285SubmittedSarah Chen
CC-17822.8.4Clinical Summary11.6PDF12,240OverdueCarlos Mendez
CC-18825.5.8Study Reports – Clinical Pharmacology8.6HTML12,241DraftLieselotte van der Berg
CC-19822.4.4Nonclinical Overview2.9XML14,162ApprovedDmitri Volkov