Request for updated SmPC section 4.1
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0100. Type: deficiency. Risk: medium. Category: Labeling.
Correspondence ID
COR-200
Type
deficiency
Application
Authority
Israel Ministry of Health
Category
Labeling
Risk
Medium
Due Date
2025-02-13
Status
Overdue
Owner
Lieselotte van der Berg
Created
2023-05-01
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0100, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_200.xlsxattachment_200_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-13 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.