CHG-2022-0091
Formulation Change for Kcluximab. Facility Change for Kcluximab — critical change. Impacts 4 markets and 3 variations.
Change Number
CHG-2022-0091
Type
Formulation Change
Product
Status
Active
Owner
Lieselotte van der Berg
Initiated
2022-10-22
Description
Facility Change for Kcluximab — critical change
Impacted Markets (4)
EU — European UnionCA — CanadaFR — FranceKR — South Korea
Impacted Modules
2.3.P4.2.13.2.P.33.2.P
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0051-V451 | Major | TFDA-2024-0051 | Failed | 2023-11-28 | — |
| HSA-2023-0052-V452 | Type II | HSA-2023-0052 | In Progress | 2023-06-03 | — |
| CDSCO-2022-0053-V453 | Type II | CDSCO-2022-0053 | Pending | 2024-01-09 | — |