Request for updated SmPC section 4.1

Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0031. Type: query. Risk: low. Category: Administrative.

Correspondence ID
COR-431
Type
query
Application
TFDA-2024-0031
Authority
Taiwan Food and Drug Administration
Category
Administrative
Risk
Low
Due Date
2025-03-26
Status
Overdue
Owner
Priya Sharma
Created
2024-02-12
Correspondence Body
Dear TFDA Review Team, With reference to application TFDA-2024-0031, 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
study_report_431.pdfattachment_431_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.