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SmPC - Quinine sulfate Tablets BP 200mg: Change history

  • Description of update: 1) To register section 3.2.P.7 of the dossier to reflect details of the blister packaging material. 2) To remove reference to the heat seal lacquer from section 6.5 of the SmPC.

    There have been no changes to the blister packaging material itself, only an update in the supporting dossier details. There are no changes to the leaflet and labelling text.

    SmPC section(s) updated– 6.5, 10

    No changes to artwork

    • Changes: (Updated: 31 May 2023)

      Description of update: 1) To register section 3.2.P.7 of the dossier to reflect details of the blister packaging material. 2) To remove reference to the heat seal lacquer from section 6.5 of the SmPC.

      There have been no changes to the blister packaging material itself, only an update in the supporting dossier details. There are no changes to the leaflet and labelling text.

      SmPC section(s) updated– 6.5, 10

      No changes to artwork

    • Changes: (Updated: 22 Mar 2023)

      Variation Description: To update sections 3 (300mg strength only), 4.4 and 4.6 of the SmPC to include the sodium excipient declaration and make editorial updates. Consequently, the PIL has been updated.

      SmPC sections updated – 3 (300mg only), 4.4, 4.6 and 10.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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