Dossier DOS-002

Dossier in NeeS format, version 6.8.9, for application EMA-2023-0002. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-002
Format
NeeS
Version
6.8.9
Status
Approved
Application
EMA-2023-0002
Created
2022-10-08
Updated
2023-03-20
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information14Completed
2CTD Summaries4Pending
3Quality13In Progress
4Nonclinical Study Reports4Overdue
5Clinical Study Reports7In Progress
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0023.5.5Drug Product9.3Word12,430BlockedTomoko Ikeda
CC-1024.1.8Pharmacokinetics Studies9.7PDF10,432In ProgressLieselotte van der Berg
CC-2023.9.3Analytical Methods7.5XML736FailedLieselotte van der Berg
CC-3025.1.5Study Reports – Clinical Pharmacology5.7Word5,482DraftPriya Sharma
CC-4021.7.6Proposed Conditions of Approval1.5XML4,389SubmittedSarah Chen
CC-5024.8.6Toxicology Studies5.9Word6,465PendingPriya Sharma
CC-6025.5.2Study Reports – Clinical Pharmacology5.2PDF3,279ApprovedPriya Sharma
CC-7021.9.9Prescribing Information1.3XML3,109ApprovedAisha Okonkwo
CC-8024.6.7Carcinogenicity1.8XML10,420SubmittedJames O'Brien
CC-9023.6.9Stability Data10.7Word1,634In ProgressPriya Sharma
CC-10025.8.8Integrated Summary of Safety5.9XML4,428PendingTomoko Ikeda
CC-11021.1.3Cover Letter3.7PDF13,372OverdueNadia Petrova
CC-12023.9.4Container Closure System1.7HTML1,552BlockedAisha Okonkwo
CC-13022.6.8Quality Overall Summary6.7PDF1,438OverdueSarah Chen
CC-14021.9.1Proposed Conditions of Approval7.0Word7,229CompletedJames O'Brien
CC-15024.9.3Carcinogenicity10.5HTML1,284ActivePriya Sharma
CC-16023.2.1Manufacturing Process5.4XML4,929ActiveCarlos Mendez
CC-17022.5.2Clinical Overview5.1PDF14,652BlockedPriya Sharma
CC-18024.4.5Toxicology Studies7.6HTML9,454CompletedPriya Sharma
CC-19025.2.9Integrated Summary of Safety6.3Word8,553DraftAisha Okonkwo