CHG-2024-0009
Specification Change for Raredimab. New Dosage Strength for Raredimab — minor update. Impacts 2 markets and 1 variations.
Change Number
CHG-2024-0009
Type
Specification Change
Product
Status
Failed
Owner
Tomoko Ikeda
Initiated
2023-04-08
Description
New Dosage Strength for Raredimab — minor update
Impacted Markets (2)
DE — GermanyTW — Taiwan
Impacted Modules
3.2.P
Linked Variations (1)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0041-V041 | Type IB | FDA-2024-0041 | Overdue | 2024-02-25 | — |