Deficiency: inadequate paediatric data justification
Correspondence from Swissmedic regarding SwissMedic-2021-0009. Type: commitment-request. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-209
Type
commitment-request
Application
Authority
Swissmedic
Category
Nonclinical
Risk
Medium
Due Date
2025-04-06
Status
Open
Owner
Carlos Mendez
Created
2023-01-18
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0009, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
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_209.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.