PIL - Fluorouracil 50 mg/ml Solution for Injection or Infusion: Change history
View Patient Information Leaflet (PIL - 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.
PIL sections updated: 6 only.
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.
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