Request for updated SmPC section 4.1
Correspondence from Health Canada regarding HC-2024-0066. Type: deficiency. Risk: low. Category: Quality.
Correspondence ID
COR-566
Type
deficiency
Application
Authority
Health Canada
Category
Quality
Risk
Low
Due Date
2024-12-15
Status
Overdue
Owner
Priya Sharma
Created
2022-04-26
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0066, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_566_1.pdfdata_table_566.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.