Dossier DOS-089

Dossier in NeeS format, version 8.8.8, for application SwissMedic-2021-0089. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-089
Format
NeeS
Version
8.8.8
Status
Approved
Application
SwissMedic-2021-0089
Created
2022-08-04
Updated
2023-02-10
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information4Draft
2CTD Summaries9Pending
3Quality9Approved
4Nonclinical Study Reports10In Progress
5Clinical Study Reports5Overdue
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0893.7.6Analytical Methods12.0Word5,919PendingDmitri Volkov
CC-1893.4.6Drug Product11.9HTML3,503OverdueSarah Chen
CC-2892.2.5Clinical Overview12.9HTML5,603BlockedMarcus Webb
CC-3894.5.6Toxicology Studies8.5XML806OverdueJames O'Brien
CC-4891.1.5Proposed Conditions of Approval1.8Word9,813ApprovedNadia Petrova
CC-5892.1.1Quality Overall Summary10.8Word6,222ActiveAisha Okonkwo
CC-6895.3.7Integrated Summary of Efficacy1.4PDF3,339DraftNadia Petrova
CC-7892.4.2Clinical Summary11.4HTML975OverduePriya Sharma
CC-8894.3.9Genotoxicity2.2Word4,235PendingDmitri Volkov
CC-9891.8.5Cover Letter1.2XML1,936CompletedSarah Chen
CC-10891.3.7Application Form2.6PDF5,872BlockedLieselotte van der Berg
CC-11892.1.4Quality Overall Summary2.5PDF4,148FailedSarah Chen
CC-12894.2.7Pharmacokinetics Studies1.9HTML6,681ActiveSarah Chen
CC-13894.3.9Toxicology Studies8.3HTML8,640DraftPriya Sharma
CC-14891.1.7Cover Letter12.0XML5,973BlockedMarcus Webb
CC-15894.4.6Pharmacology Studies6.8XML9,929FailedAisha Okonkwo
CC-16891.3.9Application Form7.4XML4,431DraftSarah Chen
CC-17891.1.1Application Form9.7XML2,613SubmittedJames O'Brien
CC-18891.7.8Prescribing Information3.6PDF9,490FailedSarah Chen
CC-19895.3.3Study Reports – Efficacy7.5XML5,482ActiveTomoko Ikeda