PIL - Fesoterodine fumarate Accord 8 mg Prolonged-release Tablets: Change history
View Patient Information Leaflet (PIL - Fesoterodine fumarate Accord 8 mg Prolonged-release Tablets)
Last updated on this site: 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).
PIL sections updated: Introduction, 2, 4, 5 and 6.
Last updated on this site: 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).
PIL sections updated: Introduction, 2, 4, 5 and 6.
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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).
PIL sections updated: Introduction, 2, 4, 5 and 6.
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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