CHG-2024-0061
Manufacturing Process Change for Kcluximab. Analytical Method Change for Kcluximab — critical change. Impacts 6 markets and 3 variations.
Change Number
CHG-2024-0061
Type
Manufacturing Process Change
Product
Status
Active
Owner
James O'Brien
Initiated
2023-11-26
Description
Analytical Method Change for Kcluximab — critical change
Impacted Markets (6)
CN — ChinaGB — United KingdomFR — FranceIT — ItalyAT — AustriaDK — Denmark
Impacted Modules
5.3.53.2.P.3
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0001-V301 | Major | FDA-2024-0001 | Approved | 2022-11-07 | 2024-03-05 |
| EMA-2023-0002-V302 | Minor | EMA-2023-0002 | Pending | — | — |
| PMDA-2022-0003-V303 | Type IA | PMDA-2022-0003 | Approved | 2023-05-08 | 2024-03-30 |