SmPC - Furosemide Tablets BP 40mg: Change history
View Summary of Product Characteristics (SmPC - Furosemide Tablets BP 40mg)
Last updated on this site: 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.
SmPC Sections updated: 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.1, 6.6, 7, 8, 9 and 10.
Last updated on this site: 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.
SmPC Sections updated: 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.1, 6.6, 7, 8, 9 and 10.
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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.
SmPC Sections updated: 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.1, 6.6, 7, 8, 9 and 10.
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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.
SmPC Sections updated: 4.5 & 10.
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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.
SmPC Sections updated: 2, 3 and 10.
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Changes: (Updated: 10 May 2023)
Single Variation
Variation type: IB, B.II.e.1.z
Variation Description: To register a module 32p7 covering the PVC blister lidded with aluminium. SmPC section 6.5 has been updated deleting obsolete packing.
Note: Additionally, details of heat seal lacquer have been removed from SmPC Section 6.5.
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Changes: (Updated: 20 Sep 2022)
Initial upload