SmPC - Spironolactone Tablets BP 25mg: Change history
View Summary of Product Characteristics (SmPC - Spironolactone Tablets BP 25mg)
Last updated on this site: 05 Nov 2024
To update SmPC sections 4.6 and 5.3 in line with the reference product Aldactone 25mg, 50mg, 100mg Film-coated Tablets – PL 00057/0928, 0929, 0927 (MAH: Pfizer Limited). No consequential update to the PIL.
Last updated on this site: 05 Nov 2024
To update SmPC sections 4.6 and 5.3 in line with the reference product Aldactone 25mg, 50mg, 100mg Film-coated Tablets – PL 00057/0928, 0929, 0927 (MAH: Pfizer Limited). No consequential update to the PIL.
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Changes: (Updated: 05 Nov 2024)
To update SmPC sections 4.6 and 5.3 in line with the reference product Aldactone 25mg, 50mg, 100mg Film-coated Tablets – PL 00057/0928, 0929, 0927 (MAH: Pfizer Limited). No consequential update to the PIL.
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Changes: (Updated: 14 Feb 2024)
Description of update:
- To update sections 4.3, 4.4, 4.5, 4.8, 5.2 and 5.3 of the SmPC and PIL in line with the reference product Aldactone 25mg Film-coated Tablets (PL00057/0928, Pfizer Ltd, May 2019).
- Additionally the section 4.4 of the SmPC and section 2 of PIL has been updated to include information on sodium excipients.
- Update to the ATC code in section 5.1 of the SmPC.
- Update to the tablet description in section 6 of the PIL at request of PIQ.
SmPC Sections updated: 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3 and 10.
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Changes: (Updated: 09 Nov 2023)
Description of update: To register M.3.2.P.7 Container Closure System for 20μ Aluminium/250μ PVC blister packaging.
SmPC Sections updated: 6.5 and 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload