SmPC - Furosemide 10 mg/ml Solution for Injection or Infusion: Change history
View Summary of Product Characteristics (SmPC - Furosemide 10 mg/ml Solution for Injection or Infusion)
Last updated on this site: 18 Nov 2024
B.II.d.1.c - QUALITY CHANGES - FINISHED PRODUCT - Control of finished product - Change in the specification parameters and/or limits of the finished product - Addition of a new specification parameter to the specification with its corresponding test method - To add visible particles test to the specification of finished product
B.II.d.1.a - QUALITY CHANGES - FINISHED PRODUCT - Control of finished product - Change in the specification parameters and/or limits of the finished product - Tightening of specification limits - To tighten the finished product specification limit for Individual unknown impurities from NMT 0.2% to NMT 0.13%.
B.II.f.1.a.1 - QUALITY CHANGES - FINISHED PRODUCT - Stability - Change in the shelf-life or storage conditions of the finished product - Reduction of the shelf life of the finished product - As packaged for sale - To reduce the shelf life of the finished product for 25ml vial as packaged for sale from 36 months to 24 months when stored at 25°C
Last updated on this site: 18 Nov 2024
B.II.d.1.c - QUALITY CHANGES - FINISHED PRODUCT - Control of finished product - Change in the specification parameters and/or limits of the finished product - Addition of a new specification parameter to the specification with its corresponding test method - To add visible particles test to the specification of finished product
B.II.d.1.a - QUALITY CHANGES - FINISHED PRODUCT - Control of finished product - Change in the specification parameters and/or limits of the finished product - Tightening of specification limits - To tighten the finished product specification limit for Individual unknown impurities from NMT 0.2% to NMT 0.13%.
B.II.f.1.a.1 - QUALITY CHANGES - FINISHED PRODUCT - Stability - Change in the shelf-life or storage conditions of the finished product - Reduction of the shelf life of the finished product - As packaged for sale - To reduce the shelf life of the finished product for 25ml vial as packaged for sale from 36 months to 24 months when stored at 25°C
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Changes: (Updated: 18 Nov 2024)
B.II.d.1.c - QUALITY CHANGES - FINISHED PRODUCT - Control of finished product - Change in the specification parameters and/or limits of the finished product - Addition of a new specification parameter to the specification with its corresponding test method - To add visible particles test to the specification of finished product
B.II.d.1.a - QUALITY CHANGES - FINISHED PRODUCT - Control of finished product - Change in the specification parameters and/or limits of the finished product - Tightening of specification limits - To tighten the finished product specification limit for Individual unknown impurities from NMT 0.2% to NMT 0.13%.
B.II.f.1.a.1 - QUALITY CHANGES - FINISHED PRODUCT - Stability - Change in the shelf-life or storage conditions of the finished product - Reduction of the shelf life of the finished product - As packaged for sale - To reduce the shelf life of the finished product for 25ml vial as packaged for sale from 36 months to 24 months when stored at 25°C
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Changes: (Updated: 23 Aug 2023)
Website administration update only- no change to file
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Changes: (Updated: 21 Sep 2022)
Initial upload