Request for updated SmPC section 4.1
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0067. Type: query. Risk: high. Category: Clinical.
Correspondence ID
COR-167
Type
query
Application
Authority
Therapeutic Goods Administration
Category
Clinical
Risk
High
Due Date
2025-01-22
Status
Overdue
Owner
Carlos Mendez
Created
2024-02-02
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0067, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_167.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.