SmPC- Metformin hydrochloride 850 mg film-coated tablets: Change history

Last updated on this site: 23 Jul 2026

Renewal.

SPC sections updated: 9 and 10

Renewal approval date: 16/07/2026

Changes: (Updated: 23 Jul 2026)

Renewal.
SPC sections updated: 9 and 10
Renewal approval date: 16/07/2026
Changes: (Updated: 11 Jul 2025)

Description of update: To update section 4.4 of the SmPC and section 2 of the leaflet in line with the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002001/202404) for metformin
Date of approval: 26/06/2025
SmPC sections updated: 4.4 and 10
Changes: (Updated: 04 Sep 2023)

New product launch.
Launch date: 25/08/2023.

Changes: (Updated: 23 Jul 2026)