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SmPC - Ramipril 2.5mg Tablets: Change history

  • Single Variation

    Variation Type: IB C.I.2.a

     

    Variation Description:

    To register an update to sections 4.3, 4.4, 4.5, 4.6, 4.8 and 5.1 of the SPC in line with the reference product (Tritace 5mg Tablets; PL 04425/0358). Consequentially, the leaflet has been updated.

    Addition of ‘sodium-free’ statement in SPC section 4.4 and PIL.

    Update to product descriptions in PIL section 6.

     

    SmPC sections updated – 4.3, 4.4, 4.5, 4.6, 4.8, 5.1 and 10

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

    • Changes: (Updated: 21 Oct 2022)

      Single Variation

      Variation Type: IB C.I.2.a

       

      Variation Description:

      To register an update to sections 4.3, 4.4, 4.5, 4.6, 4.8 and 5.1 of the SPC in line with the reference product (Tritace 5mg Tablets; PL 04425/0358). Consequentially, the leaflet has been updated.

      Addition of ‘sodium-free’ statement in SPC section 4.4 and PIL.

      Update to product descriptions in PIL section 6.

       

      SmPC sections updated – 4.3, 4.4, 4.5, 4.6, 4.8, 5.1 and 10

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

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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