Deficiency letter: missing stability data for 40°C condition

Correspondence from European Medicines Agency regarding EMA-2023-0062. Type: information-request. Risk: high. Category: Quality.

Correspondence ID
COR-062
Type
information-request
Application
EMA-2023-0062
Authority
European Medicines Agency
Category
Quality
Risk
High
Due Date
2025-01-31
Status
In Progress
Owner
Nadia Petrova
Created
2023-11-30
Correspondence Body
Dear EMA Review Team, With reference to application EMA-2023-0062, we wish to address the following: [Detailed response body regarding request for benefit-risk assessment addendum] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_62_1.pdfdata_table_62.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.