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SmPC - Ferrous sulfate Tablets BP 200mg: Change history

  • Update to section 4.2 of the SmPC to bring paediatric dosage information in line with the current BNFC recommendations. Consequently, the PIL and the label have been updated.

    SmPC sections updated: 4.2 and 10

    Variation approval date: 15/07/2026

    • Changes: (Updated: 23 Jul 2026)

      Update to section 4.2 of the SmPC to bring paediatric dosage information in line with the current BNFC recommendations. Consequently, the PIL and the label have been updated.

      SmPC sections updated: 4.2 and 10

      Variation approval date: 15/07/2026

    • Changes: (Updated: 11 Mar 2026)

      To register change in immediate packaging of the finished product - add Aluminium (25μm)/paper (25g/m2) foil as an alternative to the already registered Aluminium (9μm)/glassine paper (35g/m2) foil. Consequently section 6.5 of the SPC has been updated.

    • Changes: (Updated: 31 Jul 2023)

      Variation Description: To update section 2 of the SmPC to bring in line with the MHRA letter request to include the quantities of glucose, lactose and sucrose per tablet as they are excipients with known effects.

      SmPC sections updated – 2 and 10.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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