CHG-2024-0017
Storage Condition Change for Thymosilib. Facility Change for Thymosilib — major revision. Impacts 8 markets and 2 variations.
Change Number
CHG-2024-0017
Type
Storage Condition Change
Product
Status
Draft
Owner
Nadia Petrova
Initiated
2022-08-04
Description
Facility Change for Thymosilib — major revision
Impacted Markets (8)
EU — European UnionJP — JapanAU — AustraliaFR — FranceNL — NetherlandsTW — TaiwanSG — SingaporeTR — Turkey
Impacted Modules
3.2.P3.2.S2.3.P
Linked Variations (2)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0081-V081 | Minor | FDA-2024-0081 | Completed | — | — |
| EMA-2023-0082-V082 | Type IA | EMA-2023-0082 | Active | — | — |