SmPC - Fesoterodine fumarate Accord 8 mg Prolonged-release Tablets: Change history
View Summary of Product Characteristics (SmPC - Fesoterodine fumarate Accord 8 mg Prolonged-release Tablets)
Last updated on this site: 18 Dec 2025
Description of update: IB C.I.2.a
To update sections 4.2, 4.4 and 4.8 of the SmPC and sections 3 and 4 of the leaflet in-line with the product information of reference product (TOVIAZ 4 mg & 8 mg prolonged-release tablets; MAH: Pfizer Europe, MA EEIG, Belgium; EMA procedure number EMEA/H/C/723).
Additionally, the UK has taken this opportunity to update SmPC section 6.1 and PIL section 6 to remove ‘anhydrous’ from the excipient ‘lactose anhydrous’ in line with the EP 9th edition, hydrates list.
Date of approval: 13/12/2025
SmPC sections updated: 4.2, 4.4, 4.8, 5.1, 6.1 and 10.
Last updated on this site: 18 Dec 2025
Description of update: IB C.I.2.a
To update sections 4.2, 4.4 and 4.8 of the SmPC and sections 3 and 4 of the leaflet in-line with the product information of reference product (TOVIAZ 4 mg & 8 mg prolonged-release tablets; MAH: Pfizer Europe, MA EEIG, Belgium; EMA procedure number EMEA/H/C/723).
Additionally, the UK has taken this opportunity to update SmPC section 6.1 and PIL section 6 to remove ‘anhydrous’ from the excipient ‘lactose anhydrous’ in line with the EP 9th edition, hydrates list.
Date of approval: 13/12/2025
SmPC sections updated: 4.2, 4.4, 4.8, 5.1, 6.1 and 10.
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Changes: (Updated: 18 Dec 2025)
Description of update: IB C.I.2.a
To update sections 4.2, 4.4 and 4.8 of the SmPC and sections 3 and 4 of the leaflet in-line with the product information of reference product (TOVIAZ 4 mg & 8 mg prolonged-release tablets; MAH: Pfizer Europe, MA EEIG, Belgium; EMA procedure number EMEA/H/C/723).
Additionally, the UK has taken this opportunity to update SmPC section 6.1 and PIL section 6 to remove ‘anhydrous’ from the excipient ‘lactose anhydrous’ in line with the EP 9th edition, hydrates list.
Date of approval: 13/12/2025
SmPC sections updated: 4.2, 4.4, 4.8, 5.1, 6.1 and 10.
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Changes: (Updated: 18 Aug 2023)
Description of update: To update section 4.2, 5.1 and 5.2 of SmPC and PL in line with the product information of Reference product (TOVIAZ 4/8 mg prolonged-release tablets MAH: Pfizer Europe MA EEIG, Belgium; EMA procedure number with outcome: EMEA/H/C/000723).
SmPC sections updated: 4.2, 5.1, 5.2 and 10.
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Changes: (Updated: 16 Aug 2023)
Type IB: C.I.2. a) Implementation of change(s) for which no new additional data is required to be submitted by the MAH
To update section 4.2, 5.1 and 5.2 of SmPC and PL in line with the product information of Reference product (TOVIAZ 4/8 mg prolonged-release tablets MAH: Pfizer Europe MA EEIG, Belgium; EMA procedure number with outcome: EMEA/H/C/000723).
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Changes: (Updated: 21 Sep 2022)
Initial upload