Zydelig

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idelalisib

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

Overview

This is a summary of the European public assessment report (EPAR) for Zydelig. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zydelig.

For practical information about using Zydelig, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 03/08/2018

Authorisation details

Product details
Name
Zydelig
Agency product number
EMEA/H/C/003843
Active substance
Idelalisib
International non-proprietary name (INN) or common name
idelalisib
Therapeutic area (MeSH)
  • Lymphoma, Non-Hodgkin
  • Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code
L01XX47
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.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
18/09/2014
Contact address
Carrigtohill
County Cork, T45 DP77
Ireland

Product information

07/06/2018 Zydelig - EMEA/H/C/003843 - T/0040

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
  • OTHER ANTINEOPLASTIC AGENTS

Therapeutic indication

Zydelig is indicated in combination with an anti‑CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):

  • who have received at least one prior therapy (see section 4.4), or
  • as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4).

Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).

Assessment history

Changes since initial authorisation of medicine

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