CHG-2024-0001
Analytical Method Change for Kcluximab. Specification Change for Kcluximab — minor update. Impacts 2 markets and 1 variations.
Change Number
CHG-2024-0001
Type
Analytical Method Change
Product
Status
Draft
Owner
Priya Sharma
Initiated
2023-06-20
Description
Specification Change for Kcluximab — minor update
Impacted Markets (2)
CN — ChinaES — Spain
Impacted Modules
4.2.13.2.P.3
Linked Variations (1)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0001-V001 | Minor | FDA-2024-0001 | Overdue | 2024-04-28 | — |