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PIL - Fluorouracil 50 mg/ml Solution for Injection or Infusion: Change history

  • Description of update: Type IB (B.II.d.1.z) variation for change in the limit of test Characteristics of finished product release & shelf life specification for Fluorouracil Accord 50 mg/ml, Solution for Injection or Infusion. A clear, colourless to slight yellow solution in a clear glass vial. When examined under suitable conditions of visibility it should be practically free from particles.

    PIL sections updated: 6 only.

    • Changes: (Updated: 08 Nov 2023)

      Description of update: Type IB (B.II.d.1.z) variation for change in the limit of test Characteristics of finished product release & shelf life specification for Fluorouracil Accord 50 mg/ml, Solution for Injection or Infusion. A clear, colourless to slight yellow solution in a clear glass vial. When examined under suitable conditions of visibility it should be practically free from particles.

      PIL sections updated: 6 only.

    • Changes: (Updated: 08 Aug 2023)

      Admin updates

    • Changes: (Updated: 09 Jun 2023)

      Updated to include all recent variation updates. (Last variation approval date: 15/12/2022)

      PIL sections updated: 4, 6.

    • Changes: (Updated: 30 Dec 2022)

      Updates to the SmPC in line with product information of reference product. Consequently, the PIL has been updated.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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