CHG-2024-0045
Manufacturing Process Change for Haemoferrin. Analytical Method Change for Haemoferrin — major revision. Impacts 8 markets and 5 variations.
Change Number
CHG-2024-0045
Type
Manufacturing Process Change
Product
Status
Active
Owner
Dmitri Volkov
Initiated
2022-10-14
Description
Analytical Method Change for Haemoferrin — major revision
Impacted Markets (8)
EU — European UnionCA — CanadaCH — SwitzerlandDE — GermanyZA — South AfricaPL — PolandSE — SwedenDK — Denmark
Impacted Modules
2.3.P3.2.P4.2.1
Linked Variations (5)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0021-V221 | Major | FDA-2024-0021 | Active | 2023-04-27 | — |
| EMA-2023-0022-V222 | Major | EMA-2023-0022 | Overdue | 2023-11-24 | — |
| PMDA-2022-0023-V223 | Major | PMDA-2022-0023 | Blocked | 2024-01-13 | — |
| NMPA-2021-0024-V224 | Minor | NMPA-2021-0024 | Completed | — | — |
| ANVISA-2020-0025-V225 | Type IA | ANVISA-2020-0025 | Failed | 2023-06-01 | — |