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SmPC - Epirubicin Hydrochloride 2mg/ml solution for injection or infusion: Change history

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  • View Summary of Product Characteristics (SmPC - Epirubicin Hydrochloride 2mg/ml solution for injection or infusion)

    Last updated on this site: 08 Aug 2025

    Updated section 10 following revised MHRA approval date to 29/07/2025.

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    • Changes: (Updated: 08 Aug 2025)

      Updated section 10 following revised MHRA approval date to 29/07/2025.

    • 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.

    • 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

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