Request for updated SmPC section 4.1

Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0083. Type: query. Risk: medium. Category: Administrative.

Correspondence ID
COR-083
Type
query
Application
PMDA-2022-0083
Authority
Pharmaceuticals and Medical Devices Agency
Category
Administrative
Risk
Medium
Due Date
2025-04-08
Status
Completed
Owner
Carlos Mendez
Created
2024-03-07
Correspondence Body
Dear PMDA Review Team, With reference to application PMDA-2022-0083, 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_83.xlsxstudy_report_83.pdf
Response Package
Response package assembled: RP-083