CHG-2024-0097

Facility Change for Neuravastatin. Shelf Life Extension for Neuravastatin — critical change. Impacts 4 markets and 5 variations.

Change Number
CHG-2024-0097
Type
Facility Change
Product
Neuravastatin
Status
Draft
Owner
Carlos Mendez
Initiated
2024-01-28
Description

Shelf Life Extension for Neuravastatin — critical change

Impacted Markets (4)
CN — ChinaTR — TurkeyPL — PolandBE — Belgium
Impacted Modules
5.3.53.2.P2.3.P
Linked Variations (5)
Variation #TypeApplicationStatusSubmittedApproved
FDA-2024-0081-V481Type IIFDA-2024-0081Blocked2022-11-25—
EMA-2023-0082-V482Type IBEMA-2023-0082Overdue2022-07-21—
PMDA-2022-0083-V483Type IIPMDA-2022-0083Failed2024-02-04—
NMPA-2021-0084-V484Type IANMPA-2021-0084Pending2023-03-06—
ANVISA-2020-0085-V485Type IIANVISA-2020-0085Completed2024-04-25—