PIL - Fesoterodine fumerate Accord 4 mg Prolonged-release Tablets: Change history
View Patient Information Leaflet (PIL - Fesoterodine fumerate Accord 4 mg Prolonged-release Tablets)
Last updated on this site: 07 Oct 2025
Description of update:
SmPC sections 4.4 and 4.8 for the above-listed MA have been updated in line with the reference productTOVIAZ 4 mg prolonged-release tablets - PLGB 00057/1646 (MAH: Pfizer Limited) dated 03/2024.Consequential update to the PIL.
SmPC section 6.1 and PIL section 6 have also been updated to remove the wording ‘anhydrous’ from the excipient ‘Lactose’ in line with the 9th edition EP.
Additionally, the PIL has been updated in line with QRD.
Date of approval: 02/10/2025
SmPC sections updated: 4.4, 4.8, 6.1 and 10.
Last updated on this site: 07 Oct 2025
Description of update:
SmPC sections 4.4 and 4.8 for the above-listed MA have been updated in line with the reference productTOVIAZ 4 mg prolonged-release tablets - PLGB 00057/1646 (MAH: Pfizer Limited) dated 03/2024.Consequential update to the PIL.
SmPC section 6.1 and PIL section 6 have also been updated to remove the wording ‘anhydrous’ from the excipient ‘Lactose’ in line with the 9th edition EP.
Additionally, the PIL has been updated in line with QRD.
Date of approval: 02/10/2025
SmPC sections updated: 4.4, 4.8, 6.1 and 10.
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Changes: (Updated: 07 Oct 2025)
Description of update:
SmPC sections 4.4 and 4.8 for the above-listed MA have been updated in line with the reference productTOVIAZ 4 mg prolonged-release tablets - PLGB 00057/1646 (MAH: Pfizer Limited) dated 03/2024.Consequential update to the PIL.
SmPC section 6.1 and PIL section 6 have also been updated to remove the wording ‘anhydrous’ from the excipient ‘Lactose’ in line with the 9th edition EP.
Additionally, the PIL has been updated in line with QRD.
Date of approval: 02/10/2025
SmPC sections updated: 4.4, 4.8, 6.1 and 10.
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Changes: (Updated: 11 Jul 2024)
New product launch 21/06/2024