Imbruvica

RSS

ibrutinib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 04/11/2019

Authorisation details

Product details
Name
Imbruvica
Agency product number
EMEA/H/C/003791
Active substance
Ibrutinib
International non-proprietary name (INN) or common name
ibrutinib
Therapeutic area (MeSH)
  • Lymphoma, Mantle-Cell
  • Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code
L01XE27
OrphanOrphan

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
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
21/10/2014
Contact address
Turnhoutseweg 30
2340 Beerse
Belgium

Product information

06/09/2019 Imbruvica - EMEA/H/C/003791 - PSUSA/00010301/201811

Contents

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Pharmacotherapeutic group

  • Antineoplastic agents

  • 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.

Assessment history

Changes since initial authorisation of medicine

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