Deficiency: inadequate paediatric data justification
Correspondence from Swissmedic regarding SwissMedic-2021-0049. Type: question. Risk: medium. Category: Quality.
Correspondence ID
COR-249
Type
question
Application
Authority
Swissmedic
Category
Quality
Risk
Medium
Due Date
2025-01-24
Status
Draft
Owner
Carlos Mendez
Created
2022-04-14
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0049, 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_249.xlsxattachment_249_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.