Dossier DOS-049

Dossier in eCTD format, version 1.0.9, for application SwissMedic-2021-0049. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-049
Format
eCTD
Version
1.0.9
Status
Completed
Application
SwissMedic-2021-0049
Created
2022-11-09
Updated
2023-11-02
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information14In Progress
2CTD Summaries15Approved
3Quality13Overdue
4Nonclinical Study Reports3Completed
5Clinical Study Reports15Draft
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0494.7.6Carcinogenicity2.0HTML5,074SubmittedSarah Chen
CC-1494.3.1Genotoxicity7.0XML13,969CompletedJames O'Brien
CC-2493.7.7Stability Data5.7PDF7,747ActiveJames O'Brien
CC-3491.9.5Patient Labeling4.7XML13,549ActiveCarlos Mendez
CC-4495.5.2Study Reports – Clinical Pharmacology11.9Word12,468ActiveAisha Okonkwo
CC-5491.5.3Prescribing Information4.9HTML10,387SubmittedDmitri Volkov
CC-6491.8.8Cover Letter7.8Word14,078DraftNadia Petrova
CC-7494.7.7Genotoxicity11.0HTML3,243PendingAisha Okonkwo
CC-8495.3.6Integrated Summary of Efficacy7.8XML7,341In ProgressMarcus Webb
CC-9493.8.4Analytical Methods10.9HTML12,729ActiveJames O'Brien
CC-10492.6.6Clinical Overview6.5HTML3,910OverdueJames O'Brien
CC-11493.3.5Drug Substance2.1XML11,952FailedJames O'Brien
CC-12491.4.5Prescribing Information11.7HTML11,518CompletedDmitri Volkov
CC-13495.2.9Study Reports – Clinical Pharmacology1.1HTML2,208FailedSarah Chen
CC-14493.5.7Container Closure System3.4XML1,068SubmittedMarcus Webb
CC-15492.6.7Quality Overall Summary9.0Word10,902OverdueSarah Chen
CC-16495.1.6Integrated Summary of Safety8.9HTML815CompletedJames O'Brien
CC-17494.2.6Carcinogenicity3.9XML9,964CompletedNadia Petrova
CC-18494.5.1Genotoxicity8.5PDF1,529CompletedCarlos Mendez
CC-19492.4.3Clinical Overview3.5XML8,671In ProgressLieselotte van der Berg