SmPC - Fluorouracil 50 mg/ml Solution for Injection or Infusion: Change history
View Summary of Product Characteristics (SmPC - Fluorouracil 50 mg/ml Solution for Injection or Infusion)
Last updated on this site: 03 Jun 2026
Type IB (Q.II.f.1.a.1) to reduce the shelf-life of the Fluorouracil 50 mg/ml, Solution for Injection or Infusion as packaged for sale, from 24 months to 18 months when stored at ‘Store below 25°C. Do not refrigerate or freeze. Kept the container in the outer carton in order to protect from light.
Last updated on this site: 03 Jun 2026
Type IB (Q.II.f.1.a.1) to reduce the shelf-life of the Fluorouracil 50 mg/ml, Solution for Injection or Infusion as packaged for sale, from 24 months to 18 months when stored at ‘Store below 25°C. Do not refrigerate or freeze. Kept the container in the outer carton in order to protect from light.
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Changes: (Updated: 03 Jun 2026)
Type IB (Q.II.f.1.a.1) to reduce the shelf-life of the Fluorouracil 50 mg/ml, Solution for Injection or Infusion as packaged for sale, from 24 months to 18 months when stored at ‘Store below 25°C. Do not refrigerate or freeze. Kept the container in the outer carton in order to protect from light.
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Changes: (Updated: 10 Apr 2025)
To update section 4.4, 4.8 of the SmPC and section 4 of PIL to implement the wording agreed by the PRAC following outcome of the PSUR procedure for Fluorouracil (PSUSA/00000007/202312).
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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.
SmPC sections updated: 3 and 10.
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Changes: (Updated: 08 Aug 2023)
Admin updates
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Changes: (Updated: 09 Jun 2023)
Updated to include all recent variation updates. (Last variation approval date: 15/12/2022)
SmPC sections updated: 4.2, 4.4, 4.8, 5.3
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Changes: (Updated: 30 Dec 2022)
To update sections 4.2, 4.4, 4.8, 5.2 and 5.3 of the SmPC in line with product information of reference product.
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Changes: (Updated: 21 Sep 2022)
Initial upload