Dossier DOS-062

Dossier in CTD format, version 5.5.0, for application EMA-2023-0062. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-062
Format
CTD
Version
5.5.0
Status
Draft
Application
EMA-2023-0062
Created
2022-12-28
Updated
2023-10-06
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information6Submitted
2CTD Summaries8Draft
3Quality9Completed
4Nonclinical Study Reports9Blocked
5Clinical Study Reports4Submitted
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0623.6.7Stability Data7.1XML11,996OverdueMarcus Webb
CC-1621.7.2Patient Labeling3.7HTML1,579PendingNadia Petrova
CC-2622.4.9Clinical Overview9.2HTML2,881BlockedTomoko Ikeda
CC-3621.5.1Patient Labeling3.4XML14,876ApprovedMarcus Webb
CC-4621.8.6Proposed Conditions of Approval7.6PDF2,835ApprovedMarcus Webb
CC-5622.9.9Quality Overall Summary7.0HTML2,861ApprovedAisha Okonkwo
CC-6622.7.7Nonclinical Summary1.2HTML12,366ActiveNadia Petrova
CC-7623.8.9Analytical Methods3.5Word8,409SubmittedTomoko Ikeda
CC-8623.4.6Container Closure System1.9HTML4,225ActiveCarlos Mendez
CC-9625.5.5Integrated Summary of Safety2.6PDF6,161BlockedNadia Petrova
CC-10623.9.8Stability Data9.6Word2,630ApprovedDmitri Volkov
CC-11621.9.3Proposed Conditions of Approval7.3PDF2,921ApprovedCarlos Mendez
CC-12622.3.9Nonclinical Summary5.5Word7,881ApprovedJames O'Brien
CC-13623.9.8Analytical Methods1.7Word12,814In ProgressSarah Chen
CC-14622.9.8Clinical Overview5.4PDF13,612CompletedTomoko Ikeda
CC-15624.6.6Toxicology Studies8.3PDF1,973BlockedNadia Petrova
CC-16623.8.2Manufacturing Process12.4HTML8,260BlockedLieselotte van der Berg
CC-17621.2.6Proposed Conditions of Approval5.4XML7,034FailedJames O'Brien
CC-18623.6.2Appendices3.9Word11,973FailedCarlos Mendez
CC-19624.4.5Carcinogenicity9.0XML6,392FailedPriya Sharma