Zejula

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niraparib

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

Overview

Zejula is a cancer medicine used in women with advanced ovarian cancer, which includes cancer of the ovaries, fallopian tubes (that connect the ovaries to the uterus) or the peritoneum (the lining around the abdomen). It can be used on its own for maintenance (continuing) treatment:

  • In women newly diagnosed with advanced cancer in whom the cancer has shrunk or disappeared with a platinum-based medicines;
  • in women whose cancer had relapsed (come back) after responding to previous treatment and in whom the cancer has shrunk or disappeared with a platinum-based medicine

Ovarian cancer is rare and Zejula was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 4 August 2010.

Zejula contains the active substance niraparib.

This EPAR was last updated on 09/08/2022

Authorisation details

Product details
Name
Zejula
Agency product number
EMEA/H/C/004249
Active substance
Niraparib (tosilate 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
L01XK02
Additional monitoringAdditional 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.

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
GlaxoSmithKline (Ireland) Limited
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
16/11/2017
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Product information

18/07/2022 Zejula - EMEA/H/C/004249 - R/0034

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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

Therapeutic indication

Zejula is indicated:

  • as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
  • 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

Changes since initial authorisation of medicine

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