Request for updated SmPC section 4.1

Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0039. Type: query. Risk: low. Category: Administrative.

Correspondence ID
COR-439
Type
query
Application
Roszdravnadzor-2021-0039
Authority
Ministry of Health of Russia
Category
Administrative
Risk
Low
Due Date
2025-02-17
Status
Overdue
Owner
Nadia Petrova
Created
2023-02-08
Correspondence Body
Dear Roszdravnadzor Review Team, With reference to application Roszdravnadzor-2021-0039, we wish to address the following: [Detailed response body regarding query: container closure integrity study methodology] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
study_report_439.pdfdata_table_439.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.