Request for updated SmPC section 4.1

Correspondence from Health Sciences Authority regarding HSA-2023-0012. Type: deficiency. Risk: high. Category: Administrative.

Correspondence ID
COR-012
Type
deficiency
Application
HSA-2023-0012
Authority
Health Sciences Authority
Category
Administrative
Risk
High
Due Date
2025-01-17
Status
In Progress
Owner
Carlos Mendez
Created
2023-12-08
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 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
attachment_12_1.pdfstudy_report_12.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.