Dossier DOS-088

Dossier in NeeS format, version 3.2.6, for application MHRA-2022-0088. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-088
Format
NeeS
Version
3.2.6
Status
Completed
Application
MHRA-2022-0088
Created
2022-04-03
Updated
2023-10-21
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information10Completed
2CTD Summaries5Approved
3Quality6Submitted
4Nonclinical Study Reports8Failed
5Clinical Study Reports10Active
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0882.9.7Nonclinical Overview9.0XML4,000SubmittedMarcus Webb
CC-1882.3.2Nonclinical Summary12.0XML14,988DraftDmitri Volkov
CC-2884.5.8Pharmacology Studies6.8XML8,961PendingDmitri Volkov
CC-3885.7.2Study Reports – Efficacy12.2XML6,384ApprovedAisha Okonkwo
CC-4884.4.8Toxicology Studies4.2HTML13,128CompletedTomoko Ikeda
CC-5885.9.1Study Reports – Efficacy4.5PDF5,077BlockedSarah Chen
CC-6881.8.1Proposed Conditions of Approval12.7HTML3,786CompletedPriya Sharma
CC-7884.1.5Pharmacology Studies9.6HTML12,069SubmittedDmitri Volkov
CC-8884.7.4Genotoxicity9.5HTML10,853SubmittedSarah Chen
CC-9885.2.4Study Reports – Clinical Pharmacology12.3Word5,205DraftPriya Sharma
CC-10883.1.8Analytical Methods4.0PDF7,948DraftNadia Petrova
CC-11882.5.2Quality Overall Summary11.1PDF9,414In ProgressLieselotte van der Berg
CC-12883.6.5Drug Substance4.8PDF7,485ApprovedNadia Petrova
CC-13884.8.7Genotoxicity9.9PDF3,864CompletedSarah Chen
CC-14881.8.8Prescribing Information3.6Word2,399FailedMarcus Webb
CC-15884.6.5Genotoxicity2.4PDF10,040In ProgressLieselotte van der Berg
CC-16882.8.7Clinical Summary10.7PDF6,031PendingMarcus Webb
CC-17884.5.2Genotoxicity2.8HTML14,413DraftCarlos Mendez
CC-18885.5.8Study Reports – Efficacy10.5PDF12,409BlockedSarah Chen
CC-19884.6.9Toxicology Studies12.7PDF4,874DraftPriya Sharma