PIL - Fesoterodine fumarate Accord 8 mg Prolonged-release Tablets: Change history

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.

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).