Dossier DOS-069

Dossier in CTD format, version 2.9.6, for application SwissMedic-2021-0069. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-069
Format
CTD
Version
2.9.6
Status
Submitted
Application
SwissMedic-2021-0069
Created
2022-10-01
Updated
2024-01-16
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information4Failed
2CTD Summaries7Blocked
3Quality12Pending
4Nonclinical Study Reports14Failed
5Clinical Study Reports10Active
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0693.4.1Stability Data4.7PDF11,041CompletedPriya Sharma
CC-1695.1.7Study Reports – Safety12.8HTML9,570ActiveCarlos Mendez
CC-2692.5.1Nonclinical Overview1.4XML8,722FailedCarlos Mendez
CC-3695.9.9Integrated Summary of Safety8.7XML8,284ApprovedNadia Petrova
CC-4693.9.1Stability Data8.9PDF8,549PendingLieselotte van der Berg
CC-5691.6.9Cover Letter1.5PDF5,798In ProgressSarah Chen
CC-6694.8.6Genotoxicity6.6Word3,982ApprovedCarlos Mendez
CC-7691.2.7Proposed Conditions of Approval12.2Word4,688In ProgressNadia Petrova
CC-8695.2.5Integrated Summary of Safety11.5PDF4,337DraftMarcus Webb
CC-9694.9.9Pharmacology Studies1.3HTML638OverdueLieselotte van der Berg
CC-10692.5.4Nonclinical Overview2.5PDF12,038BlockedNadia Petrova
CC-11694.2.4Toxicology Studies10.0XML3,378ApprovedCarlos Mendez
CC-12694.3.9Pharmacology Studies3.3HTML13,349FailedLieselotte van der Berg
CC-13695.3.4Integrated Summary of Safety9.6Word2,047In ProgressNadia Petrova
CC-14692.6.1Clinical Overview11.1Word2,684BlockedDmitri Volkov
CC-15693.9.4Appendices4.5HTML12,192PendingLieselotte van der Berg
CC-16693.8.4Analytical Methods5.9Word12,345DraftDmitri Volkov
CC-17694.1.6Carcinogenicity12.1Word4,876In ProgressCarlos Mendez
CC-18693.9.9Container Closure System12.6Word8,836BlockedSarah Chen
CC-19693.5.3Drug Product1.2Word8,462SubmittedPriya Sharma