SmPC - Moxifloxacin 400 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Moxifloxacin 400 mg Film-coated Tablets)
Last updated on this site: 26 Nov 2024
To update section 5.1 of the SmPC to bring in line with the EMA guidance to relocate the minimum inhibitory concentration (MIC) data from the product information
View Summary of Product Characteristics (SmPC - Moxifloxacin 400 mg Film-coated Tablets)
Last updated on this site: 26 Nov 2024
To update section 5.1 of the SmPC to bring in line with the EMA guidance to relocate the minimum inhibitory concentration (MIC) data from the product information
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Changes: (Updated: 26 Nov 2024)
To update section 5.1 of the SmPC to bring in line with the EMA guidance to relocate the minimum inhibitory concentration (MIC) data from the product information
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Changes: (Updated: 20 May 2024)
Description of update: To register section 4.4 and 4.8 of the SPC and PIL in line with PSUSA/00009231/202305 recommendations for a causal relationship between moxifloxacin (systemic use) and DRESS.
SmPC Sections updated: 4.4, 4.8 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload