Formulation Change for Ozanemolistat. New Dosage Strength for Ozanemolistat — critical change. Impacts 6 markets and 4 variations.

Change Number
CHG-2021-0176
Type
Formulation Change
Status
Failed
Owner
Nadia Petrova
Initiated
2022-10-04
Description

New Dosage Strength for Ozanemolistat — critical change

Impacted Markets (6)
EU — European UnionJP — JapanCA — CanadaKR — South KoreaIN — IndiaRU — Russia
Impacted Modules
4.2.13.2.P.33.2.S
Linked Variations (0)
Variation #TypeApplicationStatusSubmittedApproved