Dossier DOS-029

Dossier in eCTD format, version 1.7.1, for application SwissMedic-2021-0029. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-029
Format
eCTD
Version
1.7.1
Status
In Progress
Application
SwissMedic-2021-0029
Created
2022-09-28
Updated
2024-06-08
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information3Approved
2CTD Summaries3Completed
3Quality5Submitted
4Nonclinical Study Reports9Blocked
5Clinical Study Reports10Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0292.9.9Nonclinical Summary6.6Word14,443OverdueDmitri Volkov
CC-1294.7.8Pharmacokinetics Studies11.1XML1,905In ProgressPriya Sharma
CC-2295.8.9Integrated Summary of Safety6.8HTML1,496ApprovedJames O'Brien
CC-3291.2.9Application Form6.8XML3,557ApprovedTomoko Ikeda
CC-4291.5.4Patient Labeling11.4HTML13,300OverdueDmitri Volkov
CC-5291.9.5Cover Letter4.8HTML4,378FailedJames O'Brien
CC-6292.6.2Quality Overall Summary12.3HTML11,346ApprovedAisha Okonkwo
CC-7293.3.7Drug Product6.9Word5,541ActiveJames O'Brien
CC-8294.5.1Genotoxicity2.5XML6,048CompletedLieselotte van der Berg
CC-9291.7.1Cover Letter2.4HTML2,000ActiveLieselotte van der Berg
CC-10292.6.7Nonclinical Summary3.9XML13,872SubmittedDmitri Volkov
CC-11294.9.5Pharmacology Studies10.1Word13,670BlockedLieselotte van der Berg
CC-12293.3.8Drug Substance6.6HTML12,636BlockedAisha Okonkwo
CC-13294.1.6Pharmacology Studies11.1HTML3,999ApprovedMarcus Webb
CC-14291.4.6Patient Labeling6.7XML1,281CompletedLieselotte van der Berg
CC-15294.5.4Genotoxicity4.7HTML13,866CompletedCarlos Mendez
CC-16292.3.1Nonclinical Overview9.8HTML14,922ActiveSarah Chen
CC-17294.9.3Pharmacology Studies7.6HTML8,280OverdueNadia Petrova
CC-18293.7.7Appendices12.1HTML1,475CompletedSarah Chen
CC-19292.2.2Nonclinical Overview4.7Word3,317ActiveJames O'Brien