CHG-2021-0028
Storage Condition Change for Crizotinabex. Analytical Method Change for Crizotinabex — routine update. Impacts 5 markets and 5 variations.
Change Number
CHG-2021-0028
Type
Storage Condition Change
Product
Status
Approved
Owner
Nadia Petrova
Initiated
2023-10-08
Description
Analytical Method Change for Crizotinabex — routine update
Impacted Markets (5)
AU — AustraliaKR — South KoreaTW — TaiwanSG — SingaporeDK — Denmark
Impacted Modules
3.2.P4.2.12.3.P
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TITCK-2024-0036-V136 | Type IA | TITCK-2024-0036 | Completed | 2024-05-09 | — |
| SFDA-2023-0037-V137 | Major | SFDA-2023-0037 | Draft | 2023-08-13 | — |
| SAHPRA-2022-0038-V138 | Major | SAHPRA-2022-0038 | Blocked | 2023-03-05 | — |
| Roszdravnadzor-2021-0039-V139 | Major | Roszdravnadzor-2021-0039 | Draft | 2022-08-29 | — |
| MOH-IL-2020-0040-V140 | Type IB | MOH-IL-2020-0040 | Active | 2023-08-24 | — |