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Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion

  • Name:

    Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion

  • Company:
    info
  • Active Ingredients:

    Tisagenlecleucel Cell Dispersion

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/04/20

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Summary of Product Characteristics last updated on medicines.ie: 31/3/2021
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Novartis Ireland Limited

Novartis Ireland Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 31 March 2021 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • Section 5.1: Updated to include the new clinical efficacy results of CCTL019B2205J & ATC code
  • Section 6.4 & 6.5: Description of the shipping configuration updated due to approval of an alternate dry shipper for the shipment of leukapheresis material and final Kymriah product.

Updated on 28 April 2020 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 April 2020 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 April 2020 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New PIL for new product