Request for updated SmPC section 4.1
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0007. Type: deficiency. Risk: medium. Category: Administrative.
Correspondence ID
COR-507
Type
deficiency
Application
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Medium
Due Date
2024-12-13
Status
Draft
Owner
Carlos Mendez
Created
2023-02-05
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0007, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-13 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.