Request for updated SmPC section 4.1
Correspondence from Swissmedic regarding SwissMedic-2021-0069. Type: commitment-request. Risk: low. Category: Nonclinical.
Correspondence ID
COR-069
Type
commitment-request
Application
Authority
Swissmedic
Category
Nonclinical
Risk
Low
Due Date
2024-12-06
Status
Overdue
Owner
Priya Sharma
Created
2022-06-04
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 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
attachment_69_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.