CHG-2023-0046
Formulation Change for Retinavab. Analytical Method Change for Retinavab — minor update. Impacts 8 markets and 3 variations.
Change Number
CHG-2023-0046
Type
Formulation Change
Product
Status
Completed
Owner
Tomoko Ikeda
Initiated
2022-04-23
Description
Analytical Method Change for Retinavab — minor update
Impacted Markets (8)
EU — European UnionCA — CanadaCH — SwitzerlandDE — GermanyAR — ArgentinaTR — TurkeyPL — PolandPT — Portugal
Impacted Modules
5.3.5
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0026-V226 | Type IA | HC-2024-0026 | Completed | 2023-10-21 | — |
| TGA-2023-0027-V227 | Type II | TGA-2023-0027 | Failed | 2024-02-24 | — |
| MHRA-2022-0028-V228 | Type IA | MHRA-2022-0028 | In Progress | — | — |