Request for updated SmPC section 4.1
Correspondence from Health Canada regarding HC-2024-0086. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-386
Type
question
Application
Authority
Health Canada
Category
Labeling
Risk
Medium
Due Date
2025-01-24
Status
Open
Owner
Priya Sharma
Created
2023-06-13
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0086, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
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_386.pdfattachment_386_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.