Dossier DOS-028

Dossier in CTD format, version 5.8.9, for application MHRA-2022-0028. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-028
Format
CTD
Version
5.8.9
Status
Active
Application
MHRA-2022-0028
Created
2022-09-05
Updated
2024-06-18
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information15Submitted
2CTD Summaries5Completed
3Quality9Blocked
4Nonclinical Study Reports9Blocked
5Clinical Study Reports15Active
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0284.1.8Toxicology Studies7.3Word10,080ActiveSarah Chen
CC-1281.7.2Proposed Conditions of Approval6.8Word11,134PendingCarlos Mendez
CC-2281.1.3Cover Letter12.7PDF5,286OverdueDmitri Volkov
CC-3281.5.3Prescribing Information8.6PDF13,731CompletedAisha Okonkwo
CC-4282.8.9Nonclinical Overview9.8XML11,274SubmittedTomoko Ikeda
CC-5282.6.9Nonclinical Overview10.0PDF12,608OverdueNadia Petrova
CC-6281.1.9Prescribing Information3.1HTML8,077FailedJames O'Brien
CC-7284.5.5Pharmacology Studies8.1HTML7,347In ProgressLieselotte van der Berg
CC-8284.5.5Pharmacology Studies9.9HTML11,806ApprovedCarlos Mendez
CC-9285.3.5Study Reports – Safety2.3PDF7,761OverdueAisha Okonkwo
CC-10281.4.6Cover Letter3.8XML13,400ApprovedAisha Okonkwo
CC-11284.8.4Toxicology Studies6.8HTML1,144CompletedNadia Petrova
CC-12281.3.3Proposed Conditions of Approval5.1XML12,927PendingCarlos Mendez
CC-13281.1.1Prescribing Information3.1Word11,274ActiveDmitri Volkov
CC-14285.9.8Study Reports – Efficacy2.2PDF2,447In ProgressTomoko Ikeda
CC-15283.1.8Drug Substance6.5Word2,993ApprovedLieselotte van der Berg
CC-16285.7.1Integrated Summary of Safety4.8PDF11,177ActiveNadia Petrova
CC-17282.2.8Clinical Overview1.2Word7,150FailedNadia Petrova
CC-18283.9.8Stability Data8.7Word13,178DraftTomoko Ikeda
CC-19283.4.5Manufacturing Process3.0HTML9,706PendingAisha Okonkwo