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SmPC - Topotecan 1mg/ml Concentrate for solution for infusion: Change history

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  • View Summary of Product Characteristics (SmPC - Topotecan 1mg/ml Concentrate for solution for infusion)

    Last updated on this site: 02 Nov 2023

    Product information added to Accord product website: 04/11/2023.

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    • Changes: (Updated: 02 Nov 2023)

      Product information added to Accord product website: 04/11/2023.

    • Changes: (Updated: 17 May 2023)

      Description of update: Type IB variation (C.I.2.a) application to update SmPC and PIL information in-line with the product information of the reference product (Hycamtin 1mg and 4mg powder for concentrate for solution for infusion, EU Procedure number: EU/1/96/027 MAH: Sandoz Pharmaceuticals d.d).

      SmPC sections updated: 4.2, 4.3, 4.5, 4.7, 4.8, 10.

    • Changes: (Updated: 22 Sep 2022)

      Initial upload

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