CHG-2021-0008
Storage Condition Change for Alzabistat. New Dosage Strength for Alzabistat — major revision. Impacts 2 markets and 2 variations.
Change Number
CHG-2021-0008
Type
Storage Condition Change
Product
Status
Pending
Owner
Carlos Mendez
Initiated
2023-01-11
Description
New Dosage Strength for Alzabistat — major revision
Impacted Markets (2)
NL — NetherlandsRU — Russia
Impacted Modules
3.2.P.33.2.S5.3.52.3.P
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TITCK-2024-0036-V036 | Type IA | TITCK-2024-0036 | In Progress | 2022-12-20 | — |
| SFDA-2023-0037-V037 | Major | SFDA-2023-0037 | Failed | 2023-08-18 | — |