Request for updated SmPC section 4.1
Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0017. Type: information-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-517
Type
information-request
Application
Authority
Saudi Food and Drug Authority
Category
Clinical
Risk
Medium
Due Date
2025-02-12
Status
Open
Owner
Marcus Webb
Created
2023-06-24
Correspondence Body
Dear SFDA Review Team,
With reference to application SFDA-2023-0017, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.