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

  • 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.

    • 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.

    • 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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