CHG-2022-0051
Manufacturing Process Change for Lorlatenilib. Container Closure Change for Lorlatenilib — critical change. Impacts 3 markets and 3 variations.
Change Number
CHG-2022-0051
Type
Manufacturing Process Change
Product
Status
Pending
Owner
Nadia Petrova
Initiated
2022-03-27
Description
Container Closure Change for Lorlatenilib — critical change
Impacted Markets (3)
JP — JapanGB — United KingdomPL — Poland
Impacted Modules
3.2.P.3
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0051-V251 | Type IB | TFDA-2024-0051 | Pending | 2023-12-15 | — |
| HSA-2023-0052-V252 | Type II | HSA-2023-0052 | Completed | — | — |
| CDSCO-2022-0053-V253 | Type II | CDSCO-2022-0053 | Overdue | — | — |