CHG-2022-0083
Container Closure Change for Upadacitimab. Labeling Change for Upadacitimab — minor update. Impacts 2 markets and 2 variations.
Change Number
CHG-2022-0083
Type
Container Closure Change
Product
Status
Active
Owner
James O'Brien
Initiated
2023-01-08
Description
Labeling Change for Upadacitimab — minor update
Impacted Markets (2)
BR — BrazilSE — Sweden
Impacted Modules
2.3.P
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0011-V411 | Major | TFDA-2024-0011 | Blocked | 2023-01-21 | — |
| HSA-2023-0012-V412 | Type II | HSA-2023-0012 | Submitted | 2023-09-20 | — |