CHG-2024-0053
Formulation Change for Upadacitimab. Facility Change for Upadacitimab — minor update. Impacts 8 markets and 2 variations.
Change Number
CHG-2024-0053
Type
Formulation Change
Product
Status
Submitted
Owner
Marcus Webb
Initiated
2023-11-03
Description
Facility Change for Upadacitimab — minor update
Impacted Markets (8)
BR — BrazilAU — AustraliaDE — GermanyKR — South KoreaSG — SingaporeAR — ArgentinaBE — BelgiumDK — Denmark
Impacted Modules
2.3.P
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0061-V261 | Minor | FDA-2024-0061 | Active | 2022-09-12 | — |
| EMA-2023-0062-V262 | Type II | EMA-2023-0062 | Blocked | 2023-05-15 | — |