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

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 24 June 2021

File name

Kymriah REG SPC PF21-154 June 2021_clean IPHA_1624540473.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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 with revised efficacy information based on data presented in the iCSR of study CCTL019C2201.

Updated on 31 March 2021

File name

Kymriah REG SPC PF21-057 & 21-062 March 2021 IPHA_1617189515.pdf

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

File name

Kymriah REG SPC PF20-078 March 2020 clean_1588068057.pdf

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

File name

Kymriah REG SPC PF20-078 March 2020 clean_unsigned_1587027293.pdf

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

File name

Kymriah REG PIL PF2-078 March 2020_IPHA_1587027241.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New PIL for new product