SmPC- Metformin hydrochloride 1000 mg film-coated tablets: Change history
View Summary of Product Characteristics (SmPC- Metformin hydrochloride 1000 mg film-coated tablets)
Last updated on this site: 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
View Summary of Product Characteristics (SmPC- Metformin hydrochloride 1000 mg film-coated tablets)
Last updated on this site: 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
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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
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Changes: (Updated: 04 Sep 2023)
New product launch.
Launch date: 25/08/2023.