Request for benefit-risk assessment addendum
Correspondence from European Medicines Agency regarding EMA-2023-0082. Type: deficiency. Risk: medium. Category: Labeling.
Correspondence ID
COR-382
Type
deficiency
Application
Authority
European Medicines Agency
Category
Labeling
Risk
Medium
Due Date
2024-12-19
Status
Open
Owner
Carlos Mendez
Created
2022-12-09
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0082, 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
Attachments
attachment_382_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-19 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.