PIL- Metformin hydrochloride 500 mg, 850 mg, 1000 mg film-coated tablets: Change history
View Patient Information Leaflet (PIL- Metformin hydrochloride 500 mg, 850 mg, 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
PIL sections updated: 2 and 6
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
PIL sections updated: 2 and 6
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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
PIL sections updated: 2 and 6
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Changes: (Updated: 31 May 2024)
Description of update: This notification is submitted to amend the packaging components without the need to amend the SmPC. Changes notified are as follows: to register proposed mock-ups Metformin hydrochloride 500 mg film-coated tablets, Metformin hydrochloride 850 mg filmcoated tablets and Metformin hydrochloride 1000 mg film-coated tablets (PL 20075/1399, PL 20075/1400 and PL 20075/1401 respectively) to add approved all the BRS sites and changing of PIL dimensions in Blister pack PIL.
PIL sections updated: 6 only.
No changes to SmPC.
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Changes: (Updated: 04 Sep 2023)
New product launch.
Launch date: 25/08/2023.