Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion *
Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
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