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SmPC - Darunavir 800 mg Film-coated Tablets: Change history

  • Description of update: To update the SmPC and PIL of procedure DK/H/2709/001-006/DC, in accordance with the reference product Prezista, which is registered via the centralised procedure EMEA/H/C/000707, updated on 17 August 2022.

    SmPC Sections updated: 4.1(800mg only), 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.

    • Changes: (Updated: 26 Feb 2024)

      Description of update: To update the SmPC and PIL of procedure DK/H/2709/001-006/DC, in accordance with the reference product Prezista, which is registered via the centralised procedure EMEA/H/C/000707, updated on 17 August 2022.

      SmPC Sections updated: 4.1(800mg only), 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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