CHG-2021-0012

New Dosage Strength for Respiralimab. Labeling Change for Respiralimab — major revision. Impacts 8 markets and 4 variations.

Change Number
CHG-2021-0012
Type
New Dosage Strength
Product
Respiralimab
Status
Blocked
Owner
Marcus Webb
Initiated
2022-07-06
Description

Labeling Change for Respiralimab — major revision

Impacted Markets (8)
EU — European UnionJP — JapanCN — ChinaGB — United KingdomFR — FranceIT — ItalySG — SingaporeDK — Denmark
Impacted Modules
3.2.S2.3.P3.2.P
Linked Variations (4)
Variation #TypeApplicationStatusSubmittedApproved
TITCK-2024-0056-V056MinorTITCK-2024-0056Submitted2022-12-11—
SFDA-2023-0057-V057Type IBSFDA-2023-0057Active2023-05-11—
SAHPRA-2022-0058-V058MajorSAHPRA-2022-0058Draft2022-09-08—
Roszdravnadzor-2021-0059-V059Type IIRoszdravnadzor-2021-0059Draft2022-08-24—