PIL - Epirubicin Hydrochloride 2mg/ml solution for injection or infusion: Change history
View Patient Information Leaflet (PIL - Epirubicin Hydrochloride 2mg/ml solution for injection or infusion)
Last updated on this site: 05 Aug 2025
To update sections 4.2, 4.4, 4.5, 4.6, 4.8, and 5.2 of the SmPC in line with reference product (Farmorubicina 50 mg Polvere per Soluzione per Infusione: MAH: Pfizer Limited, Italy). Consequently, the PIL is updated. Editorial changes to sections 4.1 and 4.3 of the SmPC are also made.
Change to batch release arrangements and quality control testing of the finished product - Replacement of a manufacturer responsible for importation and/or batch release.
Last updated on this site: 05 Aug 2025
To update sections 4.2, 4.4, 4.5, 4.6, 4.8, and 5.2 of the SmPC in line with reference product (Farmorubicina 50 mg Polvere per Soluzione per Infusione: MAH: Pfizer Limited, Italy). Consequently, the PIL is updated. Editorial changes to sections 4.1 and 4.3 of the SmPC are also made.
Change to batch release arrangements and quality control testing of the finished product - Replacement of a manufacturer responsible for importation and/or batch release.
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Changes: (Updated: 05 Aug 2025)
To update sections 4.2, 4.4, 4.5, 4.6, 4.8, and 5.2 of the SmPC in line with reference product (Farmorubicina 50 mg Polvere per Soluzione per Infusione: MAH: Pfizer Limited, Italy). Consequently, the PIL is updated. Editorial changes to sections 4.1 and 4.3 of the SmPC are also made.
Change to batch release arrangements and quality control testing of the finished product - Replacement of a manufacturer responsible for importation and/or batch release.
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Changes: (Updated: 06 Mar 2024)
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.
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Changes: (Updated: 23 Aug 2023)
Website administration update only- no change to file
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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.
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Changes: (Updated: 20 Sep 2022)
Initial upload