Question on comparative dissolution data
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0099. Type: question. Risk: medium. Category: Administrative.
Correspondence ID
COR-599
Type
question
Application
Authority
Ministry of Health of Russia
Category
Administrative
Risk
Medium
Due Date
2025-01-30
Status
Open
Owner
Aisha Okonkwo
Created
2023-10-12
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0099, 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
attachment_599_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.