Zejula

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niraparib

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

Overview

This is a summary of the European public assessment report (EPAR) for Zejula. 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 Zejula.

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

This EPAR was last updated on 08/02/2018

Authorisation details

Product details
Name
Zejula
Agency product number
EMEA/H/C/004249
Active substance
niraparib tosylate monohydrate
International non-proprietary name (INN) or common name
niraparib
Therapeutic area (MeSH)
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XX
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
Tesaro UK Limited
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
16/11/2017
Contact address
55 Baker Street
London
W1U 7EU
United Kingdom

Product information

19/12/2017 Zejula - EMEA/H/C/004249 - IB/0001/G

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

Therapeutic indication

Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Assessment history

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