Request for updated SmPC section 4.1
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0076. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-276
Type
question
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Labeling
Risk
Medium
Due Date
2025-03-30
Status
In Progress
Owner
Sarah Chen
Created
2022-12-22
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0076, 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
study_report_276.pdfdata_table_276.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.