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PIL - Flecainide acetate Tablets: Change history

  • To update sections 4.3, 4.4, 4.5, 4.6, 4.9, 5.1, 5.2 and 5.3 of

    the SmPC in line with the reference product Tambocor 50 mg

    Tablets (MA number: PA2010/026/002; MAH: Mylan IRE

    Healthcare Limited; dated September 2020). Consequentially,

    the PIL has been updated.

    Additional minor formatting updates to SmPC section 4.5 and

    the PIL.

    • Changes: (Updated: 07 Aug 2024)

      To update sections 4.3, 4.4, 4.5, 4.6, 4.9, 5.1, 5.2 and 5.3 of

      the SmPC in line with the reference product Tambocor 50 mg

      Tablets (MA number: PA2010/026/002; MAH: Mylan IRE

      Healthcare Limited; dated September 2020). Consequentially,

      the PIL has been updated.

      Additional minor formatting updates to SmPC section 4.5 and

      the PIL.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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