Dossier DOS-008

Dossier in NeeS format, version 3.0.8, for application MHRA-2022-0008. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-008
Format
NeeS
Version
3.0.8
Status
Pending
Application
MHRA-2022-0008
Created
2022-03-13
Updated
2023-10-28
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information10Approved
2CTD Summaries3Draft
3Quality14Completed
4Nonclinical Study Reports8In Progress
5Clinical Study Reports6In Progress
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0081.8.2Proposed Conditions of Approval12.1PDF4,647DraftDmitri Volkov
CC-1083.8.3Stability Data12.6Word7,104PendingAisha Okonkwo
CC-2084.4.6Pharmacokinetics Studies5.1Word3,780ApprovedJames O'Brien
CC-3083.3.2Manufacturing Process12.6XML2,727FailedPriya Sharma
CC-4084.3.4Pharmacokinetics Studies7.9HTML12,402ActiveMarcus Webb
CC-5085.1.8Study Reports – Efficacy6.5Word13,486ApprovedJames O'Brien
CC-6085.2.1Study Reports – Clinical Pharmacology3.1PDF9,774BlockedJames O'Brien
CC-7084.9.6Genotoxicity1.1XML13,414CompletedMarcus Webb
CC-8085.2.9Integrated Summary of Safety10.2XML1,552SubmittedSarah Chen
CC-9084.9.8Pharmacokinetics Studies12.7XML14,968FailedJames O'Brien
CC-10081.9.1Application Form1.1HTML4,696SubmittedTomoko Ikeda
CC-11085.1.2Study Reports – Clinical Pharmacology8.6HTML11,208OverdueDmitri Volkov
CC-12084.9.8Pharmacology Studies10.6Word3,623CompletedDmitri Volkov
CC-13083.8.3Container Closure System8.4PDF6,482CompletedJames O'Brien
CC-14085.7.8Integrated Summary of Efficacy1.9Word10,740CompletedJames O'Brien
CC-15081.7.2Application Form2.8XML9,791PendingNadia Petrova
CC-16084.2.9Pharmacokinetics Studies11.7XML8,447CompletedMarcus Webb
CC-17084.5.5Toxicology Studies12.1Word8,861In ProgressCarlos Mendez
CC-18084.7.6Toxicology Studies7.9XML10,567ActiveJames O'Brien
CC-19083.6.5Analytical Methods10.7PDF6,148DraftNadia Petrova