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SmPC - Methofill 50mg/ml solution for injection in pre-filled syringe: Change history

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  • View Summary of Product Characteristics (SmPC - Methofill 50mg/ml solution for injection in pre-filled syringe)

    Last updated on this site: 27 Jan 2025

    Renewal approval

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    • Changes: (Updated: 27 Jan 2025)

      Renewal approval

    • Changes: (Updated: 27 Jun 2024)

      Update to SmPC section 6.5 and leaflet section 6 to remove without blister packaging details

    • Changes: (Updated: 18 Dec 2023)

      Description of update: Type IB (C.I.3.a) variation application to update section 4.6 of SmPC and to update section 2 of PIL in-line with the agreed wording of PSUFU (DE/H/PSUFU/00002014/202110) for Injexate 50 mg/ml solution for injection in pre-filled syringe.

      SmPC Sections updated: 4.6 and 10.

    • Changes: (Updated: 17 Mar 2023)

      Reupload to amend .pdf title (no change to SmPC contents)

    • Changes: (Updated: 10 Jan 2023)

      Variation update: Update the ATC Code for “Methotrexate” as published by WHO for Injexate 50 mg/ml solution for injection in pre-filled syringe.

      SmPC sections updated: 5.1 & 10.

    • Changes: (Updated: 20 Sep 2022)

      Linked to amended product entry

    • Changes: (Updated: 15 Sep 2022)

      Initial upload

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