SmPC - Febuxostat Accord 80mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Febuxostat Accord 80mg Film-coated Tablets)
Last updated on this site: 26 Jan 2023
Variation Description:
To update the sections 4.4, 4.5, 4.8 and 5.1 of the SmPC and relevant sections of the PIL in-line with the reference product (ADENURIC 80 mg & 120 mg film-coated tablets, EU procedure number: EMEA/H/C/000777; MAH: Menarini International Operations Luxembourg S.A.; Luxembourg).
Joint PIL replaced by separate PILs for each strength. Additional typographical amends and removal of Irish MA from the PIL.
SmPC section 4.2 for the 120mg strength has been updated to correct a typographical error.
SmPC sections updated – 4.2(120 mg), 4.4, 4.5, 4.8, 5.1 and 10
Last updated on this site: 26 Jan 2023
Variation Description:
To update the sections 4.4, 4.5, 4.8 and 5.1 of the SmPC and relevant sections of the PIL in-line with the reference product (ADENURIC 80 mg & 120 mg film-coated tablets, EU procedure number: EMEA/H/C/000777; MAH: Menarini International Operations Luxembourg S.A.; Luxembourg).
Joint PIL replaced by separate PILs for each strength. Additional typographical amends and removal of Irish MA from the PIL.
SmPC section 4.2 for the 120mg strength has been updated to correct a typographical error.
SmPC sections updated – 4.2(120 mg), 4.4, 4.5, 4.8, 5.1 and 10
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Changes: (Updated: 26 Jan 2023)
Variation Description:
To update the sections 4.4, 4.5, 4.8 and 5.1 of the SmPC and relevant sections of the PIL in-line with the reference product (ADENURIC 80 mg & 120 mg film-coated tablets, EU procedure number: EMEA/H/C/000777; MAH: Menarini International Operations Luxembourg S.A.; Luxembourg).
Joint PIL replaced by separate PILs for each strength. Additional typographical amends and removal of Irish MA from the PIL.
SmPC section 4.2 for the 120mg strength has been updated to correct a typographical error.
SmPC sections updated – 4.2(120 mg), 4.4, 4.5, 4.8, 5.1 and 10
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Changes: (Updated: 21 Sep 2022)
Initial upload