Deficiency: inadequate paediatric data justification
Correspondence from Swissmedic regarding SwissMedic-2021-0069. Type: deficiency. Risk: high. Category: Labeling.
Correspondence ID
COR-269
Type
deficiency
Application
Authority
Swissmedic
Category
Labeling
Risk
High
Due Date
2025-01-02
Status
In Progress
Owner
Lieselotte van der Berg
Created
2022-07-21
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0069, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-02 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.