SmPC - Anidulafungin 100mg Powder for Concentrate for Solution for Infusion: Change history

Last updated on this site: 10 Apr 2025

To update SmPC section 5.1 in line with recommendation published by EMA for relocation of MIC data from PI.

Changes: (Updated: 10 Apr 2025)

To update SmPC section 5.1 in line with recommendation published by EMA for relocation of MIC data from PI.
Changes: (Updated: 06 Oct 2023)

Description of update: MHRA approval date updated. No other changes to SmPC.
SmPC sections updated: 9 and 10 only.
Changes: (Updated: 11 Aug 2023)

Description of update: An Unlimited MA has been granted, 5 yearly PSURs will be submitted.
SmPC sections updated: 9 & 10 only.
Changes: (Updated: 20 Sep 2022)

Linked to amended product entry
Changes: (Updated: 15 Sep 2022)

Initial upload

Changes: (Updated: 10 Apr 2025)