SmPC - Metronidazole Tablets 500mg: Change history
View Summary of Product Characteristics (SmPC - Metronidazole Tablets 500mg)
Last updated on this site: 18 Oct 2023
Description of update: To update SmPC sections 4.4, 4.5 and 4.8 in line with the reference product Flagyl 400mg Tablets (PL 04425/0746; MAH Aventis Pharma Limited) dated 5th September 2023. Consequently the PIL has been updated. Further editorial amendments have been made to the PIL.
SmPC sections updated: 4.4, 4.5, 4.8 and 10.
Last updated on this site: 18 Oct 2023
Description of update: To update SmPC sections 4.4, 4.5 and 4.8 in line with the reference product Flagyl 400mg Tablets (PL 04425/0746; MAH Aventis Pharma Limited) dated 5th September 2023. Consequently the PIL has been updated. Further editorial amendments have been made to the PIL.
SmPC sections updated: 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 18 Oct 2023)
Description of update: To update SmPC sections 4.4, 4.5 and 4.8 in line with the reference product Flagyl 400mg Tablets (PL 04425/0746; MAH Aventis Pharma Limited) dated 5th September 2023. Consequently the PIL has been updated. Further editorial amendments have been made to the PIL.
SmPC sections updated: 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 18 Oct 2023)
Description of update: To update SmPC sections 4.4, 4.5 and 4.8 in line with the reference product Flagyl 400mg Tablets (PL 04425/0746; MAH Aventis Pharma Limited) dated 5th September 2023. Consequently the PIL has been updated. Further editorial amendments have been made to the PIL.
SmPC sections updated: 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 19 Apr 2023)
Variation Description: To update sections 4.4 and 4.8 of the SmPC and section 4 of the PIL to bring in line with PRAC recommendations to update the Cockayne syndrome warning for metronidazole containing medicines.
SmPC sections updated – 4.4, 4.8 and 10.
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Changes: (Updated: 17 Feb 2023)
Variation Description:
To update section 4.4 of the SmPC to remove a reference to the brand `Flagyl' and replace with the generic name `metronidazole'.
Update to the PIL to remove repetition of wording in the ‘Pregnancy and breast-feeding’ section.
SmPC sections updated – 4.4 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload