CHG-2022-0023
Labeling Change for Upadacitimab. Manufacturing Process Change for Upadacitimab — minor update. Impacts 7 markets and 3 variations.
Change Number
CHG-2022-0023
Type
Labeling Change
Product
Status
Approved
Owner
Marcus Webb
Initiated
2022-05-07
Description
Manufacturing Process Change for Upadacitimab — minor update
Impacted Markets (7)
US — United StatesCN — ChinaAU — AustraliaTR — TurkeyZA — South AfricaPL — PolandAT — Austria
Impacted Modules
3.2.P
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0011-V111 | Major | TFDA-2024-0011 | Blocked | 2023-10-14 | — |
| HSA-2023-0012-V112 | Type II | HSA-2023-0012 | Pending | 2024-02-08 | — |
| CDSCO-2022-0013-V113 | Type IA | CDSCO-2022-0013 | Active | — | — |