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PIL - Furosemide Tablets BP 40mg: Change history

  • Description of update: SmPC sections 4.1 (20mg only), 4.2 (20, 500mg only), 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, and 5.2 have been updated in line with the reference product Furosemide 40 mg Tablets - PL 28278/0014 by MAH Ipca Laboratories UK Ltd, dated 20/10/2020. Consequentially, the PIL has been updated. Additional QRD, excipient and typographical amends have been made throughout the SmPC and PIL; including heading updates to SmPC sections 1, 4.1, 4.2, 6.1, 6.6, 7, 8, and 9. Recently approved PRAC changes for interaction with aliskiren in SmPC section 4.5 and PIL have been consolidated with these TII approved changes.

    PIL sections updated: Heading, introduction, index, 1, 2, 3, 4, 5, and 6.

    • Changes: (Updated: 09 Apr 2024)

      Description of update: SmPC sections 4.1 (20mg only), 4.2 (20, 500mg only), 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, and 5.2 have been updated in line with the reference product Furosemide 40 mg Tablets - PL 28278/0014 by MAH Ipca Laboratories UK Ltd, dated 20/10/2020. Consequentially, the PIL has been updated. Additional QRD, excipient and typographical amends have been made throughout the SmPC and PIL; including heading updates to SmPC sections 1, 4.1, 4.2, 6.1, 6.6, 7, 8, and 9. Recently approved PRAC changes for interaction with aliskiren in SmPC section 4.5 and PIL have been consolidated with these TII approved changes.

      PIL sections updated: Heading, introduction, index, 1, 2, 3, 4, 5, and 6.

    • Changes: (Updated: 08 Apr 2024)

      Description of update: SmPC sections 4.1 (20mg only), 4.2 (20, 500mg only), 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, and 5.2 have been updated in line with the reference product Furosemide 40 mg Tablets - PL 28278/0014 by MAH Ipca Laboratories UK Ltd, dated 20/10/2020. Consequentially, the PIL has been updated. Additional QRD, excipient and typographical amends have been made throughout the SmPC and PIL; including heading updates to SmPC sections 1, 4.1, 4.2, 6.1, 6.6, 7, 8, and 9. Recently approved PRAC changes for interaction with aliskiren in SmPC section 4.5 and PIL have been consolidated with these TII approved changes.

      PIL sections updated: Heading, introduction, index, 1, 2, 3, 4, 5, and 6.

    • Changes: (Updated: 28 Mar 2024)

      Description of update: To update section 4.5 of the SmPC in line with PSUSA/00002254/202304 recommendations for interaction with aliskiren. Consequently, the PIL has been updated.

      PIL sections updated: 2 & 6.

    • Changes: (Updated: 25 Jan 2024)

      Description of update: To remove obsolete alternative "COX" tablet marking from the finished product specification. In addition, Section 3 of SmPC and PIL have been updated to add the full product description, section 2 of the SmPC have been updated to add Lactose warning and editorial updated has been made to 500mg PIL.

      PIL sections updated: 6 only.

    • Changes: (Updated: 11 Aug 2023)

      Website administration update.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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