Request for updated SmPC section 4.1
Correspondence from Health Sciences Authority regarding HSA-2023-0012. Type: question. Risk: low. Category: Quality.
Correspondence ID
COR-112
Type
question
Application
Authority
Health Sciences Authority
Category
Quality
Risk
Low
Due Date
2025-04-04
Status
Open
Owner
Priya Sharma
Created
2022-12-03
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0012, 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
data_table_112.xlsxattachment_112_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.