SmPC - Levofloxacin 5mg/ml Eye Drops Solution: Change history
View Summary of Product Characteristics (SmPC - Levofloxacin 5mg/ml Eye Drops Solution)
Last updated on this site: 03 Mar 2025
To update section 5.1 of the SmPC in line with the EMA request to add new text regarding EUCAST breakpoint data.
SmPC sections updated: 5.1 and 10.
View Summary of Product Characteristics (SmPC - Levofloxacin 5mg/ml Eye Drops Solution)
Last updated on this site: 03 Mar 2025
To update section 5.1 of the SmPC in line with the EMA request to add new text regarding EUCAST breakpoint data.
SmPC sections updated: 5.1 and 10.
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Changes: (Updated: 03 Mar 2025)
To update section 5.1 of the SmPC in line with the EMA request to add new text regarding EUCAST breakpoint data.
SmPC sections updated: 5.1 and 10.
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Changes: (Updated: 22 Nov 2023)
Description of update: To update section 4.8 of the SmPC in line with the MHRA safety review of fluoroquinolone antibiotics, to include frequency ‘rare’ for ADR of tendinopathies. Consequently, the PIL has been updated.
SmPC Sections updated: 4.8 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload