Request for updated SmPC section 4.1
Correspondence from Health Sciences Authority regarding HSA-2023-0032. Type: query. Risk: high. Category: Quality.
Correspondence ID
COR-032
Type
query
Application
Authority
Health Sciences Authority
Category
Quality
Risk
High
Due Date
2025-02-06
Status
Open
Owner
Nadia Petrova
Created
2022-09-17
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0032, 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
data_table_32.xlsxattachment_32_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.