Request for post-marketing commitment progress update
Correspondence from Swissmedic regarding SwissMedic-2021-0069. Type: question. Risk: low. Category: Administrative.
Correspondence ID
COR-169
Type
question
Application
Authority
Swissmedic
Category
Administrative
Risk
Low
Due Date
2025-03-26
Status
Open
Owner
Priya Sharma
Created
2023-04-16
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0069, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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_169.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.