CHG-2022-0155

New Dosage Strength for Immunovant-α. Manufacturing Process Change for Immunovant-α — major revision. Impacts 5 markets and 1 variations.

Change Number
CHG-2022-0155
Type
New Dosage Strength
Product
Immunovant-α
Status
Blocked
Owner
James O'Brien
Initiated
2022-11-28
Description

Manufacturing Process Change for Immunovant-α — major revision

Impacted Markets (5)
ES — SpainIN — IndiaMX — MexicoTR — TurkeyRU — Russia
Impacted Modules
3.2.P.32.3.P
Linked Variations (0)
Variation #TypeApplicationStatusSubmittedApproved