Deficiency letter: missing stability data for 40°C condition
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0059. Type: information-request. Risk: high. Category: Labeling.
Correspondence ID
COR-159
Type
information-request
Application
Authority
Ministry of Health of Russia
Category
Labeling
Risk
High
Due Date
2025-02-08
Status
In Progress
Owner
Priya Sharma
Created
2022-12-06
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0059, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.