Request for post-marketing commitment progress update
Correspondence from Swissmedic regarding SwissMedic-2021-0089. Type: deficiency. Risk: high. Category: Nonclinical.
Correspondence ID
COR-189
Type
deficiency
Application
Authority
Swissmedic
Category
Nonclinical
Risk
High
Due Date
2025-04-09
Status
Open
Owner
Nadia Petrova
Created
2023-08-02
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0089, 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
study_report_189.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.