PIL - Febuxostat Accord 80mg Film-Coated Tablets: Change history
View Patient Information Leaflet (PIL - 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.
PIL sections updated – Heading, introduction, 1(80 mg), 2, 3(80 mg), 4 and 6.
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.
PIL sections updated – Heading, introduction, 1(80 mg), 2, 3(80 mg), 4 and 6.
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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.
PIL sections updated – Heading, introduction, 1(80 mg), 2, 3(80 mg), 4 and 6.