Imbruvica

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ibrutinib

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

Overview

An overview of Imbruvica and why it is authorised in the EU

Imbruvica is a medicine for treating adult patients with the following blood cancers:

  • chronic lymphocytic leukaemia (CLL) in previously untreated patients and in patients who have received at least one previous treatment;
  • mantle cell lymphoma in patients whose disease does not respond to or has come back after previous treatment;
  • Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma) in patients who have had previous treatment or who cannot have chemo immunotherapy.

Imbruvica is usually used on its ownto treat these cancers . For CLL, it can be given with two other cancer medicines, bendamustine and rituximab, in patients who have received previous treatment.

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.

Further information on the orphan designations can be found on the European Medicines Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.

Imbruvica contains the active substance ibrutinib.

This EPAR was last updated on 30/08/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
21/10/2014
Contact address
Turnhoutseweg 30
2340 Beerse
Belgium

Product information

29/06/2018 Imbruvica - EMEA/H/C/003791 - X/0037

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

  • ANTINEOPLASTIC AGENTS
  • Protein kinase inhibitors

Therapeutic indication

Imbruvica is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Imbruvica as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Imbruvica is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

Imbruvica 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.

Assessment history

Changes since initial authorisation of medicine

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