CHG-2024-0029
New Dosage Strength for Atezolimumab-R. Container Closure Change for Atezolimumab-R — routine update. Impacts 5 markets and 3 variations.
Change Number
CHG-2024-0029
Type
New Dosage Strength
Product
Status
Approved
Owner
Lieselotte van der Berg
Initiated
2022-04-03
Description
Container Closure Change for Atezolimumab-R — routine update
Impacted Markets (5)
US — United StatesDE — GermanyPL — PolandSE — SwedenPT — Portugal
Impacted Modules
5.3.53.2.P.3
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0041-V141 | Major | FDA-2024-0041 | Completed | 2024-02-09 | — |
| EMA-2023-0042-V142 | Type IB | EMA-2023-0042 | Active | — | — |
| PMDA-2022-0043-V143 | Type IA | PMDA-2022-0043 | In Progress | — | — |