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SmPC- Amiloride 5mg Tablets BP: Change history

  • II, C.I.2.b: To update sections 4.4, 4.5, 4.8, 5.1 and 5.2 of the SmPC to bring in line with the reference product Amiloride HCl/Hydrochlorothiazide Teva 2.5/25 mg, 5/50mg comprimés. Consequentially, the PIL is being updated.

    • Changes: (Updated: 26 Nov 2024)

      II, C.I.2.b: To update sections 4.4, 4.5, 4.8, 5.1 and 5.2 of the SmPC to bring in line with the reference product Amiloride HCl/Hydrochlorothiazide Teva 2.5/25 mg, 5/50mg comprimés. Consequentially, the PIL is being updated.

    • Changes: (Updated: 28 Mar 2023)

      Description of update: To update the ATC code for `Amiloride' as published by WHO - Aldosterone antagonists. Consequently, section 5.1 of the SmPC has been updated.

      Sections of SmPC updated: 5.1, 10.

    • Changes: (Updated: 20 Sep 2022)

      initial upload

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