CHG-2022-0055
Facility Change for Tisagenlecleux-B. New Dosage Strength for Tisagenlecleux-B — routine update. Impacts 8 markets and 3 variations.
Change Number
CHG-2022-0055
Type
Facility Change
Product
Status
Approved
Owner
Aisha Okonkwo
Initiated
2023-12-29
Description
New Dosage Strength for Tisagenlecleux-B — routine update
Impacted Markets (8)
US — United StatesJP — JapanCA — CanadaFR — FranceES — SpainMX — MexicoPL — PolandSE — Sweden
Impacted Modules
4.2.1
Linked Variations (3)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| TFDA-2024-0071-V271 | Major | TFDA-2024-0071 | Submitted | — | — |
| HSA-2023-0072-V272 | Type IB | HSA-2023-0072 | Blocked | 2022-12-09 | — |
| CDSCO-2022-0073-V273 | Minor | CDSCO-2022-0073 | Draft | 2023-08-29 | — |