SmPC- Apixaban Accord 2.5 mg Film-coated tablets: Change history
View Summary of Product Characteristics (SmPC- Apixaban Accord 2.5 mg Film-coated tablets)
Last updated on this site: 01 Sep 2025
Description of update: To update section 4.8 of the SmPC in line with the reference product (Eliquis 2.5 mg/ 5 mg film-coated tablets; PLGB number: PLGB 54213/0001-0002; MAH: Bristol-Myers Squibb/Pfizer EEIG, Ireland). Consequently, the leaflet and Patient Alert Card is being updated. Additionally, editorial changes have been made to sections 4.2, 4.4, 4.6 of SmPC for 5 mg strength and sections 2, 3 of the leaflet.
Date of approval: 22/08/2025
SmPC sections updated: 4.8, 9 and 10
Last updated on this site: 01 Sep 2025
Description of update: To update section 4.8 of the SmPC in line with the reference product (Eliquis 2.5 mg/ 5 mg film-coated tablets; PLGB number: PLGB 54213/0001-0002; MAH: Bristol-Myers Squibb/Pfizer EEIG, Ireland). Consequently, the leaflet and Patient Alert Card is being updated. Additionally, editorial changes have been made to sections 4.2, 4.4, 4.6 of SmPC for 5 mg strength and sections 2, 3 of the leaflet.
Date of approval: 22/08/2025
SmPC sections updated: 4.8, 9 and 10
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Changes: (Updated: 01 Sep 2025)
Description of update: To update section 4.8 of the SmPC in line with the reference product (Eliquis 2.5 mg/ 5 mg film-coated tablets; PLGB number: PLGB 54213/0001-0002; MAH: Bristol-Myers Squibb/Pfizer EEIG, Ireland). Consequently, the leaflet and Patient Alert Card is being updated. Additionally, editorial changes have been made to sections 4.2, 4.4, 4.6 of SmPC for 5 mg strength and sections 2, 3 of the leaflet.
Date of approval: 22/08/2025
SmPC sections updated: 4.8, 9 and 10
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Changes: (Updated: 18 Oct 2023)
Website administration update only- no changes to file.
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Changes: (Updated: 06 Oct 2023)
Description of update: To update sections 4.2 and 5.1 of the SmPC in-line with reference product (Eliquis 2.5 mg/5 mg film coated tablets; procedure number with outcome: EMEA/H/C/002148/II/0088; MAH: Bristol Myers Squibb/Pfizer EEIG, Ireland). Additionally, to update SmPC section 4.2, 4.3, 4.4, 4.6, 4.7, 4.8, 5.1, 5.2 and PIL section 1, 2, 3 and 4 with editorial changes in line with reference product and corrected typo errors in SmPC section 5.1, 5.2 and PIL section 2, 4.
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 10.
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Changes: (Updated: 06 Oct 2023)
Description of update: To update sections 4.2 and 5.1 of the SmPC in-line with reference product (Eliquis 2.5 mg/5 mg film coated tablets; procedure number with outcome: EMEA/H/C/002148/II/0088; MAH: Bristol Myers Squibb/Pfizer EEIG, Ireland). Additionally, to update SmPC section 4.2, 4.3, 4.4, 4.6, 4.7, 4.8, 5.1, 5.2 and PIL section 1, 2, 3 and 4 with editorial changes in line with reference product and corrected typo errors in SmPC section 5.1, 5.2 and PIL section 2, 4.
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 10.
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Changes: (Updated: 01 Aug 2023)
Website administration update only- no change to file
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Changes: (Updated: 01 Aug 2023)
Website administration update only- no change to file
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Changes: (Updated: 19 Jul 2023)
New SmPC for new product