Deficiency: inadequate paediatric data justification

Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0059. Type: question. Risk: medium. Category: Quality.

Correspondence ID
COR-559
Type
question
Application
Roszdravnadzor-2021-0059
Authority
Ministry of Health of Russia
Category
Quality
Risk
Medium
Due Date
2025-04-12
Status
In Progress
Owner
Aisha Okonkwo
Created
2022-09-26
Correspondence Body
Dear Roszdravnadzor Review Team, With reference to application Roszdravnadzor-2021-0059, 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
study_report_559.pdfdata_table_559.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.