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PIL - Alendronic acid 10mg Tablets (20075/0070): Change history

  • 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.

    • 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.

    • Changes: (Updated: 27 Sep 2022)

      Initial upload

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