Request for updated SmPC section 4.1
Correspondence from European Medicines Agency regarding EMA-2023-0002. Type: query. Risk: medium. Category: Labeling.
Correspondence ID
COR-002
Type
query
Application
Authority
European Medicines Agency
Category
Labeling
Risk
Medium
Due Date
2025-04-07
Status
Draft
Owner
Sarah Chen
Created
2023-02-18
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0002, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
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: 2025-04-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.