CHG-2024-0089
Labeling Change for Atezolimumab-R. Container Closure Change for Atezolimumab-R — minor update. Impacts 8 markets and 2 variations.
Change Number
CHG-2024-0089
Type
Labeling Change
Product
Status
Approved
Owner
Tomoko Ikeda
Initiated
2022-10-02
Description
Container Closure Change for Atezolimumab-R — minor update
Impacted Markets (8)
CN — ChinaCA — CanadaDE — GermanyAR — ArgentinaRU — RussiaSE — SwedenAT — AustriaPT — Portugal
Impacted Modules
5.3.53.2.P2.3.P
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0041-V441 | Major | FDA-2024-0041 | Active | — | — |
| EMA-2023-0042-V442 | Type IA | EMA-2023-0042 | Pending | — | — |