CHG-2024-0049
Shelf Life Extension for Brextanib. Formulation Change for Brextanib — major revision. Impacts 4 markets and 3 variations.
Change Number
CHG-2024-0049
Type
Shelf Life Extension
Product
Status
Submitted
Owner
James O'Brien
Initiated
2022-10-13
Description
Formulation Change for Brextanib — major revision
Impacted Markets (4)
EU — European UnionBR — BrazilPT — PortugalDK — Denmark
Impacted Modules
3.2.P.32.3.P
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0041-V241 | Type IB | FDA-2024-0041 | Failed | 2023-04-17 | — |
| EMA-2023-0042-V242 | Type IA | EMA-2023-0042 | Blocked | 2023-05-15 | — |
| PMDA-2022-0043-V243 | Minor | PMDA-2022-0043 | Overdue | 2024-03-07 | — |