Tecartus cells dispersion for infusion
*Company:
Gilead Sciences LtdStatus:
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
Updated on 18 December 2023
File name
Tecartus IE&XI SmPC - December 2023.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 December 2023
File name
Tecartus IE&XI PIL - December 2023.pdf
Reasons for updating
- Change to other sources of information section
Updated on 27 November 2023
File name
Tecartus IE&XI SmPC - November 2023.pdf
Reasons for updating
- 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)
Updated on 27 November 2023
File name
Tecartus IE&XI PIL - November 2023.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 27 November 2023
File name
Tecartus IE&XI PIL - November 2023.pdf
Reasons for updating
- Change to section 4 - possible side effects
File name
Combined Yescarta-Tecartus Patient Alert Card_Feb2023_Ireland.pdf
Reasons for updating
- Replace File
File name
Combined Yescarta-Tecartus Handling Guide_Feb-2023_Ireland.pdf
Reasons for updating
- Replace File
File name
Combined Yescarta-Tecartus HCP Educational Material_Feb-2023_Ireland.pdf
Reasons for updating
- Replace File
Updated on 14 November 2022
File name
Tecartus (IE and XI) SmPC (November 2022).pdf
Reasons for updating
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 September 2022
File name
Tecartus (XI and IE) PIL (September 2022).pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Group of variations:
- C.I.6.a Type II variation: extension to indication (Acute Lymphoblastic Leukaemia)
- B.II.d.1.z Type IB variation to introduce a Drug Product Dose specification for the Acute Lymphoblastic Leukaemia indication.
As well as
Type II variation (C.I.11.b) to provide the 24-month follow-up data from all treated patients in cohort 1 of ZUMA-2. This submission was to fulfil the specific obligation to confirm the long-term efficacy and safety of Tecartus in adult patients with relapsed/refractory (r/r) mantle cell lymphoma (MCL) as detailed in the Conditional Marketing Authorisation for Tecartus.
Updated on 20 September 2022
File name
Tecartus (IE and XI) SmPC (September 2022).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.5 - 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- C.I.6.a Type II variation: extension to indication (Acute Lymphoblastic Leukaemia)
B.II.d.1.z Type IB variation to introduce a Drug Product Dose specification for the Acute Lymphoblastic Leukaemia indication.
Updated on 03 May 2022
File name
Tecartus SmPC IE&XI (April 2022).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 May 2022
File name
Tecartus PIL IE&XI (April 2022).pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
File name
Combined Handling Guide Ireland_Feb22.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
so that CAR-T cell-based therapies can be used in the EU/EEA also during confirmed tocilizumab shortages by treating physicians who consider that alternative suitable treatments for CRS can be used and such treatments are made available to manage this adverse reaction associated with CAR-T cell-based therapies use.
File name
Combined HCP Educational Guide Ireland_Feb22.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update so that CAR-T cell-based therapies can be used in the EU/EEA also during confirmed tocilizumab shortages by treating physicians who consider that alternative suitable treatments for CRS can be used and such treatments are made available to manage this adverse reaction associated with CAR-T cell-based therapies use.
Updated on 27 January 2022
File name
Tecartus PIL (Jan 2022).pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 27 January 2022
File name
Tecartus PIL (Jan 2022).pdf
Reasons for updating
- Change to information for healthcare professionals
Updated on 27 January 2022
File name
Tecartus SmPC (Jan 2022).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 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Combined Patient Alert Card Ireland.pdf
Reasons for updating
- Add New Doc
File name
Combined Handling Guide Ireland.pdf
Reasons for updating
- Add New Doc
File name
Combined HCP Educational Guide Ireland.pdf
Reasons for updating
- Add New Doc
Updated on 05 November 2021
File name
Tecartus SmPC - December 2020.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 November 2021
File name
Tecartus PIL XI&IE (September 2021).pdf
Reasons for updating
- New PIL for new product