SmPC - Agomelatine Accord 25mg Film-coated Tablets: Change history

Last updated on this site: 17 Apr 2023

Variation description: An unlimited MA has been granted. 3 yearly PSURs will be submitted as per the EURD list if required.

SmPC sections updated – 9 and 10.

MHRA Renewal approval date – 14/04/2023

Changes: (Updated: 17 Apr 2023)

Variation description: An unlimited MA has been granted. 3 yearly PSURs will be submitted as per the EURD list if required.
SmPC sections updated – 9 and 10.
MHRA Renewal approval date – 14/04/2023
Changes: (Updated: 20 Dec 2022)

SmPC sections updated – 9 and 10
Renewal approval date – 15/12/2022
Changes: (Updated: 20 Sep 2022)

Amended information
Changes: (Updated: 15 Sep 2022)

initial upload

Changes: (Updated: 17 Apr 2023)