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: 28 Oct 2025
The following changes have been notified:
1. Type IAIN (B.II.b.1.a): To replace Prodlekpol Sp. z.o.o., 14, Matuszewska, 03-876 Warszawa, Poland with Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as a site responsible for secondary packaging of the finished product.
2. Type IAIN (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
Last updated on this site: 28 Oct 2025
The following changes have been notified:
1. Type IAIN (B.II.b.1.a): To replace Prodlekpol Sp. z.o.o., 14, Matuszewska, 03-876 Warszawa, Poland with Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as a site responsible for secondary packaging of the finished product.
2. Type IAIN (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
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Changes: (Updated: 28 Oct 2025)
The following changes have been notified:
1. Type IAIN (B.II.b.1.a): To replace Prodlekpol Sp. z.o.o., 14, Matuszewska, 03-876 Warszawa, Poland with Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as a site responsible for secondary packaging of the finished product.
2. Type IAIN (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
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Changes: (Updated: 18 Jul 2025)
1. To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as an alternative site responsible for Batch control/testing of the finished product.
2. To register the addition of Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow, Middlesex, HA1 4HF United Kingdom as an alternative site responsible for Batch release and importation of the finished product. Consequently, the PIL has been updated.
PIL sections updated: 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