Request for updated SmPC section 4.1

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0003. Type: information-request. Risk: low. Category: Quality.

Correspondence ID
COR-303
Type
information-request
Application
PMDA-2022-0003
Authority
Pharmaceuticals and Medical Devices Agency
Category
Quality
Risk
Low
Due Date
2025-01-10
Status
Draft
Owner
James O'Brien
Created
2023-07-02
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0003, we wish to address the following: [Detailed response body regarding request for benefit-risk assessment addendum] 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_303.xlsxattachment_303_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.