SmPC - Lotprosin XL 8mg Prolonged-release Capsules, hard: Change history

Variation Description:

• To update sections 4.1, 4.2, 4.4, 4.5, 4.8, 4.9 (16mg only) and 5.1 of the SmPC and sections 2 and 4 of PIL in line with the reference product REMINYL XL 8, 16, 24mg prolonged-release capsules, hard (PL 16189/0119, 0120, 0121; MAH: Takeda UK Limited; dated 18/05/2022).

• In Addition updates to SmPC section 4.8 and PIL of the national reporting system wording, in line with QRD template Appendix V (Version 10.3).

• Editorial updates have been made to SmPC section 4.1.

• Additional minor typographical changes throughout the SmPCs and PIL.

SmPC sections updated- 4.1, 4.2, 4.4, 4.5, 4.8, 4.9 (16mg only), 5.1 and 10.

PIL sections updated- 2, 4 and 6.