SmPC - Delmosart 54mg Prolonged-release Tablets: Change history
View Summary of Product Characteristics (SmPC - Delmosart 54mg Prolonged-release Tablets)
Last updated on this site: 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.
SmPC sections updated – 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 10.
Last updated on this site: 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.
SmPC sections updated – 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 10.
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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.
SmPC sections updated – 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload