SmPC - Vildagliptin 50 mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Vildagliptin 50 mg Tablets)
Last updated on this site: 21 Aug 2025
To reduce the shelf-life of the finished product packed in Dessiflex Alu-Alu blister pack from 3 years to 2 years. Consequently, section 6.3 of the SmPC has been updated.
Last updated on this site: 21 Aug 2025
To reduce the shelf-life of the finished product packed in Dessiflex Alu-Alu blister pack from 3 years to 2 years. Consequently, section 6.3 of the SmPC has been updated.
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Changes: (Updated: 21 Aug 2025)
To reduce the shelf-life of the finished product packed in Dessiflex Alu-Alu blister pack from 3 years to 2 years. Consequently, section 6.3 of the SmPC has been updated.
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Changes: (Updated: 27 Feb 2024)
Description of update:
To update sections 4.8 and 5.1 of the SmPC in line with the reference product Galvus® 50 mg tablets (PLGB 00101/1076; MAH: Novartis Pharmaceuticals UK Limited; dated 22/06/2023). Consequently, the leaflet has been updated. Additional editorial updates have been made to the PIL.
SmPC Sections updated: 4.8, 5.1 and 10.
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Changes: (Updated: 11 Apr 2023)
Variation Description: To update section 5.1 of the SmPC in line with the reference product, Galvus® 50 mg tablets (PLGB 00101/1076 - MAH: Novartis Pharmaceuticals UK Limited) dated 23rd August 2022.
SmPC sections updated – 5.1 and 10.
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Changes: (Updated: 29 Sep 2022)
Initial upload