SmPC - Delmosart 54mg Prolonged-release Tablets: Change history

Description of update: To update sections 4.2, 4.4, 4.5, and 4.8 of the SmPC in line with the reference product Concerta XL 18 mg prolonged-release tablets (PL 00242/0372, MAH: Janssen-Cilag Limited). Consequently the PIL has been updated. Additional formatting updates have been made to sections 4.4 and 4.8 of the SPC and to the PIL.

Date of approval: 29/08/2025

SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10

Variation Description: To update sections 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, and 5.2 of the SmPC following reference product comparison update with Concerta XL 18, 27, 36, 54 mg prolonged-release tablets (PL 00242/0372, 0400, 0373, 0374; MAH: Janssen-Cilag Limited; dated 02/11/2022). Consequently, the PIL has been updated.

SmPC sections updated – 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 10.