Dossier DOS-009

Dossier in CTD format, version 2.2.2, for application SwissMedic-2021-0009. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-009
Format
CTD
Version
2.2.2
Status
Active
Application
SwissMedic-2021-0009
Created
2022-07-12
Updated
2023-06-11
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information5Submitted
2CTD Summaries12Active
3Quality7Approved
4Nonclinical Study Reports6Failed
5Clinical Study Reports4Overdue
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0092.2.2Quality Overall Summary1.3PDF11,775OverdueJames O'Brien
CC-1094.2.2Genotoxicity12.5PDF2,848SubmittedTomoko Ikeda
CC-2091.1.7Proposed Conditions of Approval5.9PDF8,720ActiveNadia Petrova
CC-3095.5.8Study Reports – Clinical Pharmacology5.5XML7,997FailedMarcus Webb
CC-4093.2.5Drug Product9.0HTML10,746SubmittedJames O'Brien
CC-5092.7.6Clinical Summary11.0XML14,912CompletedNadia Petrova
CC-6095.8.4Study Reports – Efficacy3.5XML8,757PendingJames O'Brien
CC-7092.2.6Quality Overall Summary6.9HTML6,576PendingPriya Sharma
CC-8091.4.1Proposed Conditions of Approval11.5XML13,906In ProgressTomoko Ikeda
CC-9093.8.9Container Closure System2.2Word11,484In ProgressLieselotte van der Berg
CC-10092.8.4Clinical Summary6.2HTML7,618ActiveSarah Chen
CC-11091.1.2Prescribing Information2.8HTML11,851BlockedPriya Sharma
CC-12093.3.9Drug Product5.7PDF9,481DraftTomoko Ikeda
CC-13094.2.4Pharmacology Studies11.1PDF14,398BlockedAisha Okonkwo
CC-14092.6.9Nonclinical Summary10.5HTML3,008ApprovedMarcus Webb
CC-15093.4.7Container Closure System8.8Word4,532DraftLieselotte van der Berg
CC-16093.6.8Drug Substance1.3Word12,662CompletedPriya Sharma
CC-17091.9.4Patient Labeling5.5Word5,999PendingTomoko Ikeda
CC-18093.5.6Stability Data6.7XML12,139ApprovedLieselotte van der Berg
CC-19093.2.1Analytical Methods9.7PDF12,582PendingNadia Petrova