Request for updated SmPC section 4.1

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0037. Type: deficiency. Risk: low. Category: Administrative.

Correspondence ID
COR-337
Type
deficiency
Application
SFDA-2023-0037
Authority
Saudi Food and Drug Authority
Category
Administrative
Risk
Low
Due Date
2025-03-12
Status
Overdue
Owner
Dmitri Volkov
Created
2023-08-07
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0037, we wish to address the following: [Detailed response body regarding question on comparative dissolution data] 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: 2025-03-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.