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PIL - Aripiprazole 10mg, 15mg Orodispersible Tablets: Change history

  • To update sections 4.8 and 5.1 of the SmPC in line with the

    reference product, ABILIFY 10mg orodispersible tablets (PLGB

    50697/0002, MAH: Otsuka Pharmaceutical Netherlands B.V.).

    Consequently, the PIL has been updated.

    • Changes: (Updated: 13 Sep 2023)

      To update sections 4.8 and 5.1 of the SmPC in line with the

      reference product, ABILIFY 10mg orodispersible tablets (PLGB

      50697/0002, MAH: Otsuka Pharmaceutical Netherlands B.V.).

      Consequently, the PIL has been updated.

    • Changes: (Updated: 10 Aug 2023)

      Variation Description: To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, UK as a manufacturing site responsible for batch control testing for Microbiological testing (non-sterility) of the finished product.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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