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SmPC - Moxifloxacin 400 mg Film-coated Tablets: Change history

  • 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.

    • 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.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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