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Intended for UK patients and members of the public

PIL - Zubsolv 0.7/0.18mg, 1.4/0.36mg, 2.9/0.71mg, 5.7/1.4mg, 8.6/2.1mg, 11.4/2.9mg Sublingual Tablets: Change history

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  • View Patient Information Leaflet (PIL - Zubsolv 0.7/0.18mg, 1.4/0.36mg, 2.9/0.71mg, 5.7/1.4mg, 8.6/2.1mg, 11.4/2.9mg Sublingual Tablets)

    Last updated on this site: 08 May 2025

    To change the address of the batch release site of the product (Orexo AB) from Virdings alle 32 A, 754 50 Uppsala Sweden to Virdings alle 22, 754 50 Uppsala Sweden; the leaflet and the manufacturers (P) module are updated.

    View change history

    • Changes: (Updated: 08 May 2025)

      To change the address of the batch release site of the product (Orexo AB) from Virdings alle 32 A, 754 50 Uppsala Sweden to Virdings alle 22, 754 50 Uppsala Sweden; the leaflet and the manufacturers (P) module are updated.

    • Changes: (Updated: 07 Nov 2024)

      To update sections 4.5 and 4.8 of the SmPC to add interactions with gabapentinoids and to add the adverse reaction dental caries with a frequency not known in line with PSUSA/00002113/202309. Consequently, the PIL has been updated.

    • Changes: (Updated: 02 May 2024)

      Description of update: 'UK only' added to outer packaging to comply with Windsor Framework requirement. Minor typographical amends have been made throughout the Joint PIL.

      PIL sections updated: 2 & 6.

      No changes to SmPC.

    • Changes: (Updated: 27 Apr 2023)

      Website administration update

    • Changes: (Updated: 27 Apr 2023)

      MA holder: Accord Healthcare Limited

       

      Renewal approval date – 22/03/2023

      (Renewal approval received date – 18/04/2023)

      Renewal submitted date – 04/02/2022

       

      This product is marketed in the UK

       

      An Unlimited MA has been granted, 4 yearly PSURs will be submitted.

       

      SmPC sections updated – 3, 4.1, 4.2, 4.4, 4.5, 4.8, 5.2, 5.3, 6.1, 6.4, 6.5, 9 and 10

    • Changes: (Updated: 16 Mar 2023)

      Variation Description: To update sections 4.4, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC to bring in line with the reference product (Suboxone 2 mg/0.5 mg sublingual tablets. Consequently, the PIL has been updated.

      Minor editorial changes have also been made to the PIL.

    • Changes: (Updated: 22 Sep 2022)

      Initial upload

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