Request for updated SmPC section 4.1
Correspondence from COFEPRIS regarding COFEPRIS-2021-0054. Type: query. Risk: high. Category: Nonclinical.
Correspondence ID
COR-454
Type
query
Application
Authority
COFEPRIS
Category
Nonclinical
Risk
High
Due Date
2025-03-16
Status
Draft
Owner
Dmitri Volkov
Created
2022-05-26
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0054, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_454_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.