PIL - Delmosart 18mg, 27mg, 36mg, 54mg Prolonged-release Tablets: Change history
View Patient Information Leaflet (PIL - Delmosart 18mg, 27mg, 36mg, 54mg Prolonged-release Tablets)
Last updated on this site: 16 Sep 2025
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
PIL sections updated: 3, 4 and 6
Last updated on this site: 16 Sep 2025
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
PIL sections updated: 3, 4 and 6
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Changes: (Updated: 16 Sep 2025)
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
PIL sections updated: 3, 4 and 6
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Changes: (Updated: 12 Jul 2023)
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.
PIL sections updated – 1, 2, 3, 4, 5, 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload edited to add more relations and change title
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Changes: (Updated: 21 Sep 2022)
Initial upload