Request for updated SmPC section 4.1
Correspondence from ANMAT regarding ANMAT-2020-0075. Type: information-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-275
Type
information-request
Application
Authority
ANMAT
Category
Labeling
Risk
Medium
Due Date
2024-12-23
Status
Draft
Owner
Marcus Webb
Created
2022-06-03
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0075, 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
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.