CHG-2023-0070
Shelf Life Extension for Fabrizyme-β. Container Closure Change for Fabrizyme-β — minor update. Impacts 4 markets and 5 variations.
Change Number
CHG-2023-0070
Type
Shelf Life Extension
Product
Status
Failed
Owner
Sarah Chen
Initiated
2023-02-16
Description
Container Closure Change for Fabrizyme-β — minor update
Impacted Markets (4)
DE — GermanyZA — South AfricaBE — BelgiumAT — Austria
Impacted Modules
3.2.P3.2.P.32.3.P
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0046-V346 | Minor | HC-2024-0046 | Blocked | 2023-12-03 | — |
| TGA-2023-0047-V347 | Type IA | TGA-2023-0047 | Active | 2023-02-12 | — |
| MHRA-2022-0048-V348 | Type IB | MHRA-2022-0048 | Draft | — | — |
| SwissMedic-2021-0049-V349 | Type IB | SwissMedic-2021-0049 | Completed | 2022-08-06 | — |
| MFDS-2020-0050-V350 | Type IB | MFDS-2020-0050 | Completed | 2022-08-23 | — |