CHG-2021-0068
Specification Change for Alzabistat. Labeling Change for Alzabistat — critical change. Impacts 6 markets and 5 variations.
Change Number
CHG-2021-0068
Type
Specification Change
Product
Status
Overdue
Owner
Priya Sharma
Initiated
2022-03-04
Description
Labeling Change for Alzabistat — critical change
Impacted Markets (6)
JP — JapanBR — BrazilFR — FranceIT — ItalySA — Saudi ArabiaBE — Belgium
Impacted Modules
3.2.P.3
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TITCK-2024-0036-V336 | Type IB | TITCK-2024-0036 | Approved | 2023-05-30 | 2024-01-24 |
| SFDA-2023-0037-V337 | Major | SFDA-2023-0037 | Active | 2023-07-09 | — |
| SAHPRA-2022-0038-V338 | Type IB | SAHPRA-2022-0038 | Submitted | 2023-12-29 | — |
| Roszdravnadzor-2021-0039-V339 | Major | Roszdravnadzor-2021-0039 | Approved | 2022-08-04 | 2024-07-04 |
| MOH-IL-2020-0040-V340 | Type IA | MOH-IL-2020-0040 | Draft | — | — |