SmPC - Alendronic Acid Once weekly 70 mg Tablets: Change history
View Summary of Product Characteristics (SmPC - Alendronic Acid Once weekly 70 mg Tablets)
Last updated on this site: 09 Apr 2025
IB, C.I.2.a - to update SmPC sections 4.4, 4.6, 4.7, 4.8, 5.2, 5.3 and leaflet sections 2 and 3 in-line information with the reference product (FOSAMAX Once Weekly 70 mg tablets; Procedure number: AT/H/0870/001; MAH: Organon Austria GmbH).
Additionally, applicant has updated SmPC section 4.9 and 5.2 with some editorial changes related to typographical error in-line with reference product information.
Last updated on this site: 09 Apr 2025
IB, C.I.2.a - to update SmPC sections 4.4, 4.6, 4.7, 4.8, 5.2, 5.3 and leaflet sections 2 and 3 in-line information with the reference product (FOSAMAX Once Weekly 70 mg tablets; Procedure number: AT/H/0870/001; MAH: Organon Austria GmbH).
Additionally, applicant has updated SmPC section 4.9 and 5.2 with some editorial changes related to typographical error in-line with reference product information.
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Changes: (Updated: 09 Apr 2025)
IB, C.I.2.a - to update SmPC sections 4.4, 4.6, 4.7, 4.8, 5.2, 5.3 and leaflet sections 2 and 3 in-line information with the reference product (FOSAMAX Once Weekly 70 mg tablets; Procedure number: AT/H/0870/001; MAH: Organon Austria GmbH).
Additionally, applicant has updated SmPC section 4.9 and 5.2 with some editorial changes related to typographical error in-line with reference product information.
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Changes: (Updated: 15 Aug 2024)
Minor adjustment of the quantitative composition of the finished product with respect to lactose content (SmPC section 2)
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Changes: (Updated: 26 Jun 2023)
Website administration update only- no changes to file.
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Changes: (Updated: 27 Sep 2022)
Amended name
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Changes: (Updated: 20 Sep 2022)
initial upload
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Changes: (Updated: 20 Sep 2022)
initial upload