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PIL - Methofill multi-strength Solution for Injection in Pre-filled Injector: Change history

  • Description of update: Variation type IA: A.5.b - Change in the name of Batch control/testing site from Wessling Hungary Kft., Anonymus utca 6., Budapest H-1045, Hungary to Eurofins Analytical Services Hungary Kft., Anonymus utca 6, Budapest, 1045, Hungary. A.7 - The deletion of Wessling Hungary Kft. Anonymus utca 6, Budapest, H-1045, Hungary as Batch release site.

    PIL sections updated: 6 only.

    • Changes: (Updated: 12 Feb 2024)

      Description of update: Variation type IA: A.5.b - Change in the name of Batch control/testing site from Wessling Hungary Kft., Anonymus utca 6., Budapest H-1045, Hungary to Eurofins Analytical Services Hungary Kft., Anonymus utca 6, Budapest, 1045, Hungary. A.7 - The deletion of Wessling Hungary Kft. Anonymus utca 6, Budapest, H-1045, Hungary as Batch release site.

      PIL sections updated: 6 only.

    • Changes: (Updated: 12 Dec 2023)

      Description of update:

      1. To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as QC testing site.

      2. To register the addition of Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow, Middlesex, HA1 4HF United Kingdom as Batch release and importer site. Consequentially, the PIL is updated.

      PIL sections updated: 6 only.

    • Changes: (Updated: 28 Apr 2023)

      Description of update: Variation type IB no: C.I.3.a. Update to section 4.6 of SmPC and update to section 2 of PIL in-line with the agreed wording of PSUFU (DE/H/PSUFU/00002014/202110).

      PIL sections updated: 2, 6.

    • Changes: (Updated: 12 Dec 2022)

      Re-uploaded this document for administration purposes. No additional changes have been made.

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