SmPC - Piperacillin/Tazobactam 4g/0.5g Powder for solution for infusion: Change history

Last updated on this site: 09 Apr 2025

Inclusion of the link to the EUCAST breakpoints published on EMA’s website to section 5.1 of the SmPC.

Changes: (Updated: 09 Apr 2025)

Inclusion of the link to the EUCAST breakpoints published on EMA’s website to section 5.1 of the SmPC.
Changes: (Updated: 03 Oct 2024)

Update of the SmPC sections 4.4, 5.1, leaflet section 6 and label section 3 as per the comments provided by the CMS during RUP.
Changes: (Updated: 20 May 2024)

Description of update: Change in the shelf-life or storage conditions of the finished product - Extension of the shelf life of the finished product - As packaged for sale (supported by real time data) - change in the current approved shelf-life of 24 months to 36 months
SmPC Sections updated: 6.3 and 10.
No changes to PIL.
Changes: (Updated: 20 May 2024)

New product launch.
Launch date: 15/05/2024.

Changes: (Updated: 09 Apr 2025)