Request for updated SmPC section 4.1
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0013. Type: deficiency. Risk: medium. Category: Labeling.
Correspondence ID
COR-113
Type
deficiency
Application
Authority
Central Drugs Standard Control Organisation
Category
Labeling
Risk
Medium
Due Date
2025-04-22
Status
Open
Owner
Marcus Webb
Created
2023-06-08
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0013, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_113_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.