Imbruvica
ibrutinib
Table of contents
Overview
Imbruvica is a medicine for treating adult patients with the following blood cancers:
- mantle cell lymphoma 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)
Imbruvica can be taken alone but can also be taken with bendamustine and rituximab or with obinutuzumab in certain patients with CLL and with rituximab in patients with Waldenström’s macroglobulinaemia.
These diseases are rare, and Imbruvica was designated an ‘orphan medicine’ (a medicine used in rare diseases) for chronic lymphocytic leukaemia on 26 April 2012, mantle cell lymphoma on 12 March 2013 and Waldenström’s macroglobulinaemia on 29 April 2014.
Imbruvica contains the active substance ibrutinib.
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List item
Imbruvica : EPAR - Medicine overview (PDF/130.7 KB) (updated)
First published: 25/11/2014
Last updated: 04/12/2019
EMA/438752/2019 -
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List item
Imbruvica : EPAR - Risk-management-plan summary (PDF/93.9 KB)
First published: 25/11/2014
Last updated: 25/11/2014
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 |
L01XE27
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Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International NV
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Revision |
16
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Date of issue of marketing authorisation valid throughout the European Union |
21/10/2014
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Contact address |
Product information
06/09/2019 Imbruvica - EMEA/H/C/003791 - PSUSA/00010301/201811
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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 obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
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.
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 obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
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.