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Intended for UK patients and members of the public

SmPC- Buprenorphine 2mg Sublingual Tablets: Change history

  • To update sections 4.2, 4.4, 4.5, and 4.8 of the SmPC in line

    with PRAC recommendation (EMEA/H/C/PSUSA/00000459/202309). Consequently, the PIL

    has been updated.

     

    Additional updates:

    • Update to SmPC section 4.4 to correct the medicinal name.

    • Formatting updates to SmPC sections 4.2, 4.8 and PIL.

    • Editorial updates to SmPC sections 4.4, 4.8 and PIL.

    • QRD updates to SmPC section 4.8.

    • Changes: (Updated: 05 Nov 2024)

      To update sections 4.2, 4.4, 4.5, and 4.8 of the SmPC in line

      with PRAC recommendation (EMEA/H/C/PSUSA/00000459/202309). Consequently, the PIL

      has been updated.

       

      Additional updates:

      • Update to SmPC section 4.4 to correct the medicinal name.

      • Formatting updates to SmPC sections 4.2, 4.8 and PIL.

      • Editorial updates to SmPC sections 4.4, 4.8 and PIL.

      • QRD updates to SmPC section 4.8.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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