SmPC - Idarubicin 5mg/5ml solution for injection: Change history
View Summary of Product Characteristics (SmPC - Idarubicin 5mg/5ml solution for injection)
Last updated on this site: 21 Apr 2026
Description of update: To update sections 4.4, 4.5, 4.6 of the SmPC and section 2 of the leaflet in-line with the product information of reference product (Zavedos CS 1mg/ml solution for injection; MAH: Pfizer Healthcare; procedure number: 389/NF/97).
Date of approval: 16/03/2026
SmPC sections updated: 4.4, 4.5, 4.6 and 10
View Summary of Product Characteristics (SmPC - Idarubicin 5mg/5ml solution for injection)
Last updated on this site: 21 Apr 2026
Description of update: To update sections 4.4, 4.5, 4.6 of the SmPC and section 2 of the leaflet in-line with the product information of reference product (Zavedos CS 1mg/ml solution for injection; MAH: Pfizer Healthcare; procedure number: 389/NF/97).
Date of approval: 16/03/2026
SmPC sections updated: 4.4, 4.5, 4.6 and 10
-
Changes: (Updated: 21 Apr 2026)
Description of update: To update sections 4.4, 4.5, 4.6 of the SmPC and section 2 of the leaflet in-line with the product information of reference product (Zavedos CS 1mg/ml solution for injection; MAH: Pfizer Healthcare; procedure number: 389/NF/97).
Date of approval: 16/03/2026
SmPC sections updated: 4.4, 4.5, 4.6 and 10
-
Changes: (Updated: 20 Sep 2022)
Initial upload