CHG-2022-0019
Container Closure Change for Brextanib. Labeling Change for Brextanib — critical change. Impacts 7 markets and 5 variations.
Change Number
CHG-2022-0019
Type
Container Closure Change
Product
Status
In Progress
Owner
Lieselotte van der Berg
Initiated
2023-02-06
Description
Labeling Change for Brextanib — critical change
Impacted Markets (7)
BR — BrazilCA — CanadaDE — GermanyIT — ItalyTW — TaiwanZA — South AfricaBE — Belgium
Impacted Modules
3.2.P3.2.S
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0091-V091 | Minor | TFDA-2024-0091 | Submitted | — | — |
| HSA-2023-0092-V092 | Minor | HSA-2023-0092 | Active | 2023-05-15 | — |
| CDSCO-2022-0093-V093 | Type IA | CDSCO-2022-0093 | Pending | 2022-09-07 | — |
| COFEPRIS-2021-0094-V094 | Type II | COFEPRIS-2021-0094 | Draft | 2022-08-06 | — |
| ANMAT-2020-0095-V095 | Type IA | ANMAT-2020-0095 | Pending | 2023-05-25 | — |