SmPC - Epirubicin Hydrochloride 2mg/ml solution for injection or infusion: Change history
View Summary of Product Characteristics (SmPC - Epirubicin Hydrochloride 2mg/ml solution for injection or infusion)
Last updated on this site: 08 Mar 2024
Description of update: To update the PIL and sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1 and 5.2 of the SPC in-line with reference product information (FARMORUBICINA 10 mg/5 mL Powder and Solvent for Solution for Infusion; MA number: 025197068; MAH: Pfizer Italia S.r.l.) for Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion.
SmPC Sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 &10.
Last updated on this site: 08 Mar 2024
Description of update: To update the PIL and sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1 and 5.2 of the SPC in-line with reference product information (FARMORUBICINA 10 mg/5 mL Powder and Solvent for Solution for Infusion; MA number: 025197068; MAH: Pfizer Italia S.r.l.) for Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion.
SmPC Sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 &10.
-
Changes: (Updated: 08 Mar 2024)
Description of update: To update the PIL and sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1 and 5.2 of the SPC in-line with reference product information (FARMORUBICINA 10 mg/5 mL Powder and Solvent for Solution for Infusion; MA number: 025197068; MAH: Pfizer Italia S.r.l.) for Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion.
SmPC Sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 &10.
-
Changes: (Updated: 23 Aug 2023)
Website administration update only- no change to file
-
Changes: (Updated: 06 Dec 2022)
Section 4.4 and 4.5 - in line with the Product information of reference product (Pharmorubicin 2 mg/ml Solution for Injection or Infusion with procedure number:PL 00057/1023 & MAH: Pfizer Limited) for Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion.
-
Changes: (Updated: 20 Sep 2022)
Initial upload