CHG-2024-0021
Labeling Change for Lorlatenilib. Shelf Life Extension for Lorlatenilib — minor update. Impacts 8 markets and 1 variations.
Change Number
CHG-2024-0021
Type
Labeling Change
Product
Status
Draft
Owner
Sarah Chen
Initiated
2022-01-25
Description
Shelf Life Extension for Lorlatenilib — minor update
Impacted Markets (8)
EU — European UnionBR — BrazilAU — AustraliaDE — GermanySG — SingaporeTR — TurkeyRU — RussiaPT — Portugal
Impacted Modules
5.3.54.2.13.2.S
Linked Variations (1)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0001-V101 | Type IA | FDA-2024-0001 | Pending | 2023-12-07 | — |