CHG-2021-0016
Storage Condition Change for Retinavab. Manufacturing Process Change for Retinavab — minor update. Impacts 5 markets and 4 variations.
Change Number
CHG-2021-0016
Type
Storage Condition Change
Product
Status
Blocked
Owner
James O'Brien
Initiated
2023-12-21
Description
Manufacturing Process Change for Retinavab — minor update
Impacted Markets (5)
JP — JapanCN — ChinaDE — GermanyZA — South AfricaAT — Austria
Impacted Modules
2.3.P3.2.P5.3.5
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TITCK-2024-0076-V076 | Minor | TITCK-2024-0076 | Draft | 2023-02-04 | — |
| SFDA-2023-0077-V077 | Type IB | SFDA-2023-0077 | Overdue | 2023-09-18 | — |
| SAHPRA-2022-0078-V078 | Type II | SAHPRA-2022-0078 | Completed | — | — |
| Roszdravnadzor-2021-0079-V079 | Type II | Roszdravnadzor-2021-0079 | Draft | — | — |