Request for updated SmPC section 4.1

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0043. Type: query. Risk: low. Category: Administrative.

Correspondence ID
COR-343
Type
query
Application
PMDA-2022-0043
Authority
Pharmaceuticals and Medical Devices Agency
Category
Administrative
Risk
Low
Due Date
2024-12-23
Status
Draft
Owner
Nadia Petrova
Created
2023-02-02
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0043, 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_343.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.