Request for updated SmPC section 4.1
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0091. Type: commitment-request. Risk: low. Category: Quality.
Correspondence ID
COR-291
Type
commitment-request
Application
Authority
Taiwan Food and Drug Administration
Category
Quality
Risk
Low
Due Date
2024-12-23
Status
Draft
Owner
James O'Brien
Created
2023-11-30
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0091, 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_291_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.