CHG-2022-0011
Labeling Change for Infectivir. Manufacturing Process Change for Infectivir — critical change. Impacts 7 markets and 5 variations.
Change Number
CHG-2022-0011
Type
Labeling Change
Product
Status
Draft
Owner
Sarah Chen
Initiated
2023-12-28
Description
Manufacturing Process Change for Infectivir — critical change
Impacted Markets (7)
US — United StatesCA — CanadaKR — South KoreaTW — TaiwanSE — SwedenPT — PortugalDK — Denmark
Impacted Modules
3.2.S3.2.P4.2.1
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0051-V051 | Type II | TFDA-2024-0051 | Failed | — | — |
| HSA-2023-0052-V052 | Type IB | HSA-2023-0052 | Failed | — | — |
| CDSCO-2022-0053-V053 | Minor | CDSCO-2022-0053 | Active | — | — |
| COFEPRIS-2021-0054-V054 | Type IA | COFEPRIS-2021-0054 | Overdue | 2023-01-11 | — |
| ANMAT-2020-0055-V055 | Minor | ANMAT-2020-0055 | Completed | — | — |