Request for updated SmPC section 4.1

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0058. Type: query. Risk: medium. Category: Administrative.

Correspondence ID
COR-158
Type
query
Application
SAHPRA-2022-0058
Authority
South African Health Products Regulatory Authority
Category
Administrative
Risk
Medium
Due Date
2024-12-14
Status
In Progress
Owner
Sarah Chen
Created
2023-12-17
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0058, we wish to address the following: [Detailed response body regarding deficiency: inadequate paediatric data justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_158_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.