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 (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.

This EPAR was last updated on 24/05/2023

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
L01EL01
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
21/10/2014
Contact address
Turnhoutseweg 30
2340 Beerse
Belgium

Product information

03/04/2023 Imbruvica - EMEA/H/C/003791 - IB/0079

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Product information documents contain:

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

  • 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 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

Changes since initial authorisation of medicine

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