CHG-2021-0100
Formulation Change for Fabrizyme-β. Storage Condition Change for Fabrizyme-β — routine update. Impacts 6 markets and 4 variations.
Change Number
CHG-2021-0100
Type
Formulation Change
Product
Status
Completed
Owner
Priya Sharma
Initiated
2022-07-29
Description
Storage Condition Change for Fabrizyme-β — routine update
Impacted Markets (6)
EU — European UnionIT — ItalyTW — TaiwanIN — IndiaRU — RussiaBE — Belgium
Impacted Modules
3.2.P5.3.5
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TITCK-2024-0096-V496 | Type II | TITCK-2024-0096 | Pending | 2022-09-09 | — |
| SFDA-2023-0097-V497 | Type IB | SFDA-2023-0097 | Overdue | 2024-04-09 | — |
| SAHPRA-2022-0098-V498 | Major | SAHPRA-2022-0098 | Pending | — | — |
| Roszdravnadzor-2021-0099-V499 | Type II | Roszdravnadzor-2021-0099 | Submitted | 2023-07-31 | — |