Request for updated SmPC section 4.1
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0050. Type: question. Risk: low. Category: Labeling.
Correspondence ID
COR-250
Type
question
Application
Authority
Ministry of Food and Drug Safety
Category
Labeling
Risk
Low
Due Date
2025-02-15
Status
Open
Owner
Tomoko Ikeda
Created
2023-07-14
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0050, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_250_1.pdfdata_table_250.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.