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PIL - Delmosart 18mg, 27mg, 36mg, 54mg Prolonged-release Tablets: Change history

  • Variation Description: To update sections 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, and 5.2 of the SmPC following reference product comparison update with Concerta XL 18, 27, 36, 54 mg prolonged-release tablets (PL 00242/0372, 0400, 0373, 0374; MAH: Janssen-Cilag Limited; dated 02/11/2022). Consequently, the PIL has been updated.

    PIL sections updated – 1, 2, 3, 4, 5, 6.

    • Changes: (Updated: 12 Jul 2023)

      Variation Description: To update sections 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, and 5.2 of the SmPC following reference product comparison update with Concerta XL 18, 27, 36, 54 mg prolonged-release tablets (PL 00242/0372, 0400, 0373, 0374; MAH: Janssen-Cilag Limited; dated 02/11/2022). Consequently, the PIL has been updated.

      PIL sections updated – 1, 2, 3, 4, 5, 6.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload edited to add more relations and change title

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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