CHG-2021-0072

Manufacturing Process Change for Respiralimab. Storage Condition Change for Respiralimab — major revision. Impacts 6 markets and 4 variations.

Change Number
CHG-2021-0072
Type
Manufacturing Process Change
Product
Respiralimab
Status
Approved
Owner
James O'Brien
Initiated
2023-01-24
Description

Storage Condition Change for Respiralimab — major revision

Impacted Markets (6)
DE — GermanyFR — FranceKR — South KoreaRU — RussiaPL — PolandAT — Austria
Impacted Modules
3.2.S3.2.P4.2.15.3.5
Linked Variations (4)
Variation #TypeApplicationStatusSubmittedApproved
TITCK-2024-0056-V356Type IBTITCK-2024-0056Submitted2023-08-15—
SFDA-2023-0057-V357Type IISFDA-2023-0057Failed2023-02-12—
SAHPRA-2022-0058-V358Type IBSAHPRA-2022-0058Failed2023-09-12—
Roszdravnadzor-2021-0059-V359Type IARoszdravnadzor-2021-0059Completed2023-08-21—