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PIL - Lynlor 5mg, 10mg, 20mg Capsules, hard: Change history

  • To update sections 4.2, 4.4, 4.6, and 4.8 of the SPC in line with the Reference Product, Oxy Norm 5, 10, 20 mg Capsules (PL 16950/0106, 0107, 0108, MAH: Napp Pharmaceuticals Ltd, dated 08/03/2024). Consequently, the PIL has been updated.

     

    Editorial updates made to the PIL in line with the SPC sections 4.2 and 4.4 and QRD.

    • Changes: (Updated: 05 Nov 2024)

      To update sections 4.2, 4.4, 4.6, and 4.8 of the SPC in line with the Reference Product, Oxy Norm 5, 10, 20 mg Capsules (PL 16950/0106, 0107, 0108, MAH: Napp Pharmaceuticals Ltd, dated 08/03/2024). Consequently, the PIL has been updated.

       

      Editorial updates made to the PIL in line with the SPC sections 4.2 and 4.4 and QRD.

    • Changes: (Updated: 28 Mar 2024)

      Description of update: To update sections 4.4 and 4.8 in line with PSUSA/00002254/202204 (Oxycodone and risk of SOD). Consequently, the PIL has been updated. Additional editorial updates have been made to the PIL.

      PIL sections updated: Header, 2, 4 and 6.

    • Changes: (Updated: 17 May 2023)

      Variation Description: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC in line with PRAC recommendations (PSUSA/00002254/202204) for opioid use disorder and overdose. Consequently, the PIL has also been updated.

      PIL sections updated – 2, 3, 4, 5 and 6.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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