Request for benefit-risk assessment addendum
Correspondence from Swissmedic regarding SwissMedic-2021-0089. Type: information-request. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-089
Type
information-request
Application
Authority
Swissmedic
Category
Nonclinical
Risk
Medium
Due Date
2025-02-23
Status
Draft
Owner
Lieselotte van der Berg
Created
2022-10-13
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
attachment_89_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.