CHG-2024-0085
New Dosage Strength for Tisagenlecleux-B. Analytical Method Change for Tisagenlecleux-B — critical change. Impacts 7 markets and 4 variations.
Change Number
CHG-2024-0085
Type
New Dosage Strength
Product
Status
Approved
Owner
Priya Sharma
Initiated
2022-11-25
Description
Analytical Method Change for Tisagenlecleux-B — critical change
Impacted Markets (7)
CN — ChinaBR — BrazilFR — FranceIT — ItalyTR — TurkeyRU — RussiaSE — Sweden
Impacted Modules
3.2.P.34.2.13.2.P
Linked Variations (4)
| Variation # | Type | Application | Status | Submitted | Approved |
|---|---|---|---|---|---|
| FDA-2024-0021-V421 | Type IA | FDA-2024-0021 | Approved | 2023-12-05 | 2024-07-04 |
| EMA-2023-0022-V422 | Major | EMA-2023-0022 | Pending | 2023-09-11 | — |
| PMDA-2022-0023-V423 | Type II | PMDA-2022-0023 | Failed | 2023-03-11 | — |
| NMPA-2021-0024-V424 | Type II | NMPA-2021-0024 | Active | 2023-05-20 | — |