CHG-2024-0077

Labeling Change for Thymosilib. Specification Change for Thymosilib — routine update. Impacts 7 markets and 4 variations.

Change Number
CHG-2024-0077
Type
Labeling Change
Product
Thymosilib
Status
Overdue
Owner
Tomoko Ikeda
Initiated
2023-06-22
Description

Specification Change for Thymosilib — routine update

Impacted Markets (7)
JP — JapanIT — ItalyES — SpainSG — SingaporeIN — IndiaAT — AustriaPT — Portugal
Impacted Modules
3.2.P3.2.S4.2.15.3.5
Linked Variations (4)
Variation #TypeApplicationStatusSubmittedApproved
FDA-2024-0081-V381Type IAFDA-2024-0081Overdue——
EMA-2023-0082-V382Type IBEMA-2023-0082Draft2023-11-02—
PMDA-2022-0083-V383Type IBPMDA-2022-0083Draft——
NMPA-2021-0084-V384Type IINMPA-2021-0084Draft2022-12-07—