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Intended for UK patients and members of the public

PIL - Lercanidipine hydrochloride 10mg, 20mg Film-coated tablet: Change history

  • 1.Type IAIN (B.II.b.1.a) variation application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.

     

    2.Type IAIN (B.II.b.2.C.2) variation application to add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.

    Consequentially updated UK PIL mock-up.

    • Changes: (Updated: 07 Jul 2025)

      1.Type IAIN (B.II.b.1.a) variation application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.

       

      2.Type IAIN (B.II.b.2.C.2) variation application to add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.

      Consequentially updated UK PIL mock-up.

    • Changes: (Updated: 21 Oct 2022)

      Variation approval date: 14/10/2022

       

      Single Variation

      Variation Type: IB, C.I.2.a

       

      Variation Description: SmPC & PIL update in line with the reference product, Zanidip. An editorial update has been made to SmPC section 3 for the 20mg SmPC to change the word “colored” to “coloured”.

       

      SmPC sections updated – 3 (20mg only), 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10

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

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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