Imbruvica
ibrutinib
Table of contents
Overview
Imbruvica is a medicine for treating adult patients with the following blood cancers:
- mantle cell lymphoma (MCL) in patients whose disease does not respond to or has come back after previous treatment;
- chronic lymphocytic leukaemia (CLL) in both previously treated and untreated patients;
- Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma).
For the treatment of MCL, Imbruvica is taken on its own. For CLL, Imbruvica can be taken on its own but can also be taken with bendamustine and rituximab, or with either obinutuzumab, rituximab or venetoclax. For patients with Waldenström’s macroglobulinaemia, Imbruvica is taken on its own or with rituximab.
Imbruvica contains the active substance ibrutinib.
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List item
Imbruvica : EPAR - Medicine overview (PDF/145.18 KB)
First published: 25/11/2014
Last updated: 22/09/2022
EMA/635597/2022 -
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List item
Imbruvica : EPAR - Risk-management-plan summary (PDF/268.8 KB) (updated)
First published: 25/11/2014
Last updated: 24/05/2023
Authorisation details
Product details | |
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Name |
Imbruvica
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Agency product number |
EMEA/H/C/003791
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Active substance |
Ibrutinib
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International non-proprietary name (INN) or common name |
ibrutinib
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
L01EL01
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Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International NV
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Revision |
30
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Date of issue of marketing authorisation valid throughout the European Union |
21/10/2014
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Contact address |
Turnhoutseweg 30
2340 Beerse Belgium |
Product information
03/04/2023 Imbruvica - EMEA/H/C/003791 - IB/0079
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Antineoplastic agents
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Protein kinase inhibitors
Therapeutic indication
IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).
IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 202327/01/2023
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24/06/2022
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29/10/2021
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03/09/2021
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24/07/2020
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28/06/2019
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22/07/2016
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29/04/2016
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22/05/2015
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22/05/2015
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25/07/2014
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25/07/2014