Deficiency letter: missing stability data for 40°C condition

Correspondence from European Medicines Agency regarding EMA-2023-0002. Type: information-request. Risk: high. Category: Administrative.

Correspondence ID
COR-202
Type
information-request
Application
EMA-2023-0002
Authority
European Medicines Agency
Category
Administrative
Risk
High
Due Date
2025-02-19
Status
In Progress
Owner
Lieselotte van der Berg
Created
2023-07-25
Correspondence Body
Dear EMA Review Team, With reference to application EMA-2023-0002, we wish to address the following: [Detailed response body regarding request for post-marketing commitment progress update] 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: 2025-02-19 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.