SmPC - Delmosart 18mg Prolonged-release Tablets: Change history

Last updated on this site: 11 Apr 2024

Correction made to section 9 "Date of first authorisation/renewal of the authorisation":

Date amended from 15/11/2019 to 19/07/2016.

No other changes.

Changes: (Updated: 11 Apr 2024)

Correction made to section 9 "Date of first authorisation/renewal of the authorisation":
Date amended from 15/11/2019 to 19/07/2016.
No other changes.
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.
Changes: (Updated: 21 Sep 2022)

Initial upload

Changes: (Updated: 11 Apr 2024)