Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion
*Company:
Novartis Ireland LimitedStatus:
UpdatedLegal 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
- SPC
- Patient Leaflets
- Ed Material - HCP
- Ed Material - Patient
- Additional Comms
- Licence Info
- Doc History
Updated on 27 November 2024
File name
Kymriah REG PIL PF24-219 November 2024_clean IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Change in name of manufacturer responsible for batch release
Updated on 06 August 2024
File name
Kymriah REG SPC PF24-016 August 2024 clean IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 updated with information about the risk of T cell malignancies.
Section 4.8 updated with new ADR 'secondary malignancy of T cell origin' (frequency ‘rare’) and two ADRs moved from post marketing experience to the ADR table: anaphylactic reaction (frequency ‘not known’), neurotoxicity (frequency ‘not known’)
Updated on 06 August 2024
File name
Kymriah REG PIL PF24-016 August 2024_clean IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Information added regarding the risk of developing a T cell cancer
File name
DHPC_-_Secondary_Malignancy_-_HPRA_Final-Signed.docx.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
DHPC - Issued on 18-July-2024
File name
Novartis Kymriah Patient Alert Card RMPx4pgs-FINAL.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Add new doc
Updated on 25 April 2024
File name
Kymriah REG SPC PF24-045 February 2024 clean IPHA.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update Sections 5.1 and 5.2 with data from CCTL019B2202 and CCTL019C2201
Updated on 25 April 2024
File name
Kymriah REG SPC PF23-084 February 2023 clean IPHA.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update Sections 5.1 and 5.2 with data from CCTL019B2202 and CCTL019C2201
Updated on 03 May 2023
File name
Kymriah REG SPC PF23-084 April 2023 clean IPHA.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.9 - Overdose
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes due to renewal of the Marketing Authorisation
Updated on 03 May 2023
File name
Kymriah REG PIL PF23-084 April 2023_Nuremberg_clean IPHA.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
Changes due to renewal of the Marketing Authorisation
File name
KYMRIAH RMP HCP Training Program Slides - June 2022_Clean.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
First upload to medicines.ie
File name
A310822 Novartis Kymriah Pharmacy Cell Lab Infusion Centre - FINAL Online.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
First upload to medicines.ie
File name
A326122 Novartis Kymriah Patient Education Leaflet FINAL Online.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
First upload to medicines.ie
Updated on 14 November 2022
File name
Kymriah REG SPC PF22-205_October 2022 clean IPHA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- 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 4.2: The B-cell ALL subsection of “Paediatric Population” section has been updated with “Currently available data in this age group are described in sections 4.8 and 5.1”
Section 4.8: Updated to include a new section on the safety of tisagenlecleucel in r/r B-cell ALL paediatric patients
Section 5.1: Updated to include paediatric data from the observational study B2401.
Updated on 19 October 2022
File name
Kymriah REG SPC PF22-174_15.09.22_clean IPHA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
SmPC update with pooled safety data from the 3 ALL studies CCTL019B2202, CCTL019B2205J and CCTL019B2001X
Section 4.2: Information for pediatric populations amended
Section 4.4: Amendments to sections on ‘Neurological events’ and ‘Prior treatment with anti‑CD19 therapy’
Section 4.8: Updated to reflect data from studies CCTL019B2205J and CCTL019B2001X
Section 5.1: Updated to include pediatric data from Phase II study BIANCA C2022
Updated on 19 October 2022
File name
Kymriah REG PIL PF22-174_15.09.22_Nuremberg_clean IPHA.docx.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Use in Children & Adolescents amended to refer to limited experience in pediatric patients below 3 years of age in B ALL. Kymriah is not recommended to be used in children and adolescents below 18 years of age to treat DBLCL due to limited experience. Kymriah should not be used in children and adolescents below 18 years of age to treat FL. This is because Kymriah has not been studied in this age group.
Changes to frequency of following side effects: 'Raised blood pressure' (changed from 'common' to 'very common') and 'Abnormal blood test results (high level of magnesium)' (change from 'very common' to 'uncommon') and "low levels of magnesium' (from 'very common' to 'common')
Updated on 05 May 2022
File name
Kymriah REG SPC PF21-203 April 2022_clean IPHA.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes due to ne Follicular Lymphoma indicaiton
Updated on 05 May 2022
File name
Kymriah REG PIL PF21-203 April 2022_clean IPHA.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Changes due to new Follicular Lymphoma indication
Updated on 15 February 2022
File name
Kymriah REG SPC PF22-037 February 2022_clean.pdf
Reasons for updating
- 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
Minor amendments to reflect change in shipping configuration without metal cassette
Updated on 31 January 2022
File name
Kymriah REG PIL PF22-003 January 2022_clean IPHA.pdf
Reasons for updating
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Update to 'Information for Healthcare Professionals' section to include instuctions for CRS management in the event of a tocilizumab shortage.
Updated on 31 January 2022
File name
Kymriah REG SPC PF22-003 January 2022_clean IPHA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to SmPC supporting treatment with Kymriah in the event of tocilizumab EU shortage:
- Section 4.2: In the exceptional case where tocilizumab is not available due to a shortage that is listed in the European Medicines Agency shortage catalogue, suitable alternative measures to treat CRS instead of tocilizumab must be available prior to infusion.
- Section 4.4: In the exceptional case where tocilizumab is not available due to a shortage that is listed in the European Medicines Agency shortage catalogue, the treatment centre must have access to suitable alternative measures instead of tocilizumab to treat CRS.
Updated on 24 June 2021
File name
Kymriah REG SPC PF21-154 June 2021_clean IPHA.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.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.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.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.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new product