SmPC - Risedronate sodium Accord once a week 35 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Risedronate sodium Accord once a week 35 mg Film-coated Tablets)
Last updated on this site: 07 Oct 2024
Last updated on this site: 07 Oct 2024
To update SmPC sections 2, 4.2, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2 and PIL in line with reference product, Risontel Once a week 35mg film-coated Tablets (MA Number: PA0126/197/001; MAH: Clonmel; Dated: February 2021).
Additionally, SmPC section 4.8 has been updated in line with MedDRA. SmPC section 1, 4.8 and PIL have also been updated in line with QRD guidelines.
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Changes: (Updated: 07 Oct 2024)
To update SmPC sections 2, 4.2, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2 and PIL in line with reference product, Risontel Once a week 35mg film-coated Tablets (MA Number: PA0126/197/001; MAH: Clonmel; Dated: February 2021).
Additionally, SmPC section 4.8 has been updated in line with MedDRA. SmPC section 1, 4.8 and PIL have also been updated in line with QRD guidelines.
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Changes: (Updated: 24 Apr 2023)
Website administration update
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Changes: (Updated: 21 Sep 2022)
Initial upload