CHG-2023-0010
Facility Change for Fabrizyme-β. Formulation Change for Fabrizyme-β — critical change. Impacts 3 markets and 4 variations.
Change Number
CHG-2023-0010
Type
Facility Change
Product
Status
Draft
Owner
Lieselotte van der Berg
Initiated
2023-12-09
Description
Formulation Change for Fabrizyme-β — critical change
Impacted Markets (3)
CN — ChinaBR — BrazilSA — Saudi Arabia
Impacted Modules
2.3.P3.2.S
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| HC-2024-0046-V046 | Type IB | HC-2024-0046 | Blocked | 2022-08-03 | — |
| TGA-2023-0047-V047 | Minor | TGA-2023-0047 | Submitted | — | — |
| MHRA-2022-0048-V048 | Minor | MHRA-2022-0048 | Blocked | 2022-11-27 | — |
| SwissMedic-2021-0049-V049 | Major | SwissMedic-2021-0049 | Failed | 2023-03-17 | — |