Request for updated SmPC section 4.1
Correspondence from COFEPRIS regarding COFEPRIS-2021-0074. Type: deficiency. Risk: low. Category: Nonclinical.
Correspondence ID
COR-574
Type
deficiency
Application
Authority
COFEPRIS
Category
Nonclinical
Risk
Low
Due Date
2025-02-07
Status
Open
Owner
Priya Sharma
Created
2023-02-16
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0074, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_574_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.