Deficiency: inadequate paediatric data justification
Correspondence from Health Canada regarding HC-2024-0006. Type: information-request. Risk: low. Category: Administrative.
Correspondence ID
COR-006
Type
information-request
Application
Authority
Health Canada
Category
Administrative
Risk
Low
Due Date
2025-03-30
Status
Draft
Owner
Sarah Chen
Created
2023-01-18
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0006, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_6.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.