CHG-2022-0079
Container Closure Change for Brextanib. New Dosage Strength for Brextanib — critical change. Impacts 7 markets and 2 variations.
Change Number
CHG-2022-0079
Type
Container Closure Change
Product
Status
Submitted
Owner
Dmitri Volkov
Initiated
2022-11-03
Description
New Dosage Strength for Brextanib — critical change
Impacted Markets (7)
CN — ChinaCA — CanadaCH — SwitzerlandKR — South KoreaSG — SingaporeSA — Saudi ArabiaZA — South Africa
Impacted Modules
3.2.P5.3.52.3.P4.2.1
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0091-V391 | Type IB | TFDA-2024-0091 | Completed | 2024-04-15 | — |
| HSA-2023-0092-V392 | Type IB | HSA-2023-0092 | Overdue | 2022-09-07 | — |