CHG-2022-0059
Specification Change for Atezolimumab-R. New Dosage Strength for Atezolimumab-R — critical change. Impacts 3 markets and 4 variations.
Change Number
CHG-2022-0059
Type
Specification Change
Product
Status
Active
Owner
Aisha Okonkwo
Initiated
2023-12-22
Description
New Dosage Strength for Atezolimumab-R — critical change
Impacted Markets (3)
MX — MexicoRU — RussiaSE — Sweden
Impacted Modules
3.2.S
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0091-V291 | Type II | TFDA-2024-0091 | Failed | 2024-01-01 | — |
| HSA-2023-0092-V292 | Type II | HSA-2023-0092 | In Progress | 2024-01-15 | — |
| CDSCO-2022-0093-V293 | Type IA | CDSCO-2022-0093 | Submitted | — | — |
| COFEPRIS-2021-0094-V294 | Type IA | COFEPRIS-2021-0094 | In Progress | — | — |