CHG-2021-0060

Specification Change for Mavacamtamex. Manufacturing Process Change for Mavacamtamex — routine update. Impacts 6 markets and 5 variations.

Change Number
CHG-2021-0060
Type
Specification Change
Product
Mavacamtamex
Status
Submitted
Owner
James O'Brien
Initiated
2023-04-14
Description

Manufacturing Process Change for Mavacamtamex — routine update

Impacted Markets (6)
CA — CanadaFR — FranceTW — TaiwanMX — MexicoAR — ArgentinaTR — Turkey
Impacted Modules
4.2.13.2.P.3
Linked Variations (5)
Variation #TypeApplicationStatusSubmittedApproved
TITCK-2024-0096-V296Type IBTITCK-2024-0096Overdue——
SFDA-2023-0097-V297Type IISFDA-2023-0097Failed2023-11-25—
SAHPRA-2022-0098-V298MajorSAHPRA-2022-0098Approved2023-03-212023-11-30
Roszdravnadzor-2021-0099-V299Type IBRoszdravnadzor-2021-0099Completed——
MOH-IL-2020-0100-V300Type IIMOH-IL-2020-0100Submitted2023-06-24—