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: 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.
Last updated on this site: 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.
-
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.
-
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)
SmPC sections updated: 4.2, 4.4, 4.8, 5.3
-
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.
-
Changes: (Updated: 21 Sep 2022)
Initial upload