CHG-2024-0081
Formulation Change for Lorlatenilib. Formulation Change for Lorlatenilib — routine update. Impacts 6 markets and 4 variations.
Change Number
CHG-2024-0081
Type
Formulation Change
Product
Status
Submitted
Owner
Tomoko Ikeda
Initiated
2023-05-02
Description
Formulation Change for Lorlatenilib — routine update
Impacted Markets (6)
GB — United KingdomMX — MexicoSE — SwedenBE — BelgiumPT — PortugalDK — Denmark
Impacted Modules
3.2.P.3
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0001-V401 | Major | FDA-2024-0001 | Active | 2024-05-26 | — |
| EMA-2023-0002-V402 | Type IB | EMA-2023-0002 | Submitted | 2023-10-31 | — |
| PMDA-2022-0003-V403 | Type IB | PMDA-2022-0003 | Overdue | 2023-09-04 | — |
| NMPA-2021-0004-V404 | Type IA | NMPA-2021-0004 | Overdue | — | — |