CHG-2022-0031
Formulation Change for Kcluximab. New Dosage Strength for Kcluximab — critical change. Impacts 2 markets and 2 variations.
Change Number
CHG-2022-0031
Type
Formulation Change
Product
Status
In Progress
Owner
James O'Brien
Initiated
2022-12-18
Description
New Dosage Strength for Kcluximab — critical change
Impacted Markets (2)
CN — ChinaTW — Taiwan
Impacted Modules
5.3.53.2.P.34.2.1
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0051-V151 | Type IA | TFDA-2024-0051 | Draft | 2022-08-26 | — |
| HSA-2023-0052-V152 | Major | HSA-2023-0052 | Failed | — | — |