Request for updated SmPC section 4.1

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0098. Type: query. Risk: medium. Category: Labeling.

Correspondence ID
COR-598
Type
query
Application
SAHPRA-2022-0098
Authority
South African Health Products Regulatory Authority
Category
Labeling
Risk
Medium
Due Date
2024-12-10
Status
Overdue
Owner
Sarah Chen
Created
2022-05-31
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0098, 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
data_table_598.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.