Question on comparative dissolution data
Correspondence from European Medicines Agency regarding EMA-2023-0022. Type: deficiency. Risk: low. Category: Labeling.
Correspondence ID
COR-022
Type
deficiency
Application
Authority
European Medicines Agency
Category
Labeling
Risk
Low
Due Date
2025-03-14
Status
Open
Owner
Marcus Webb
Created
2023-02-15
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0022, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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_22.pdfdata_table_22.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.