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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.
Zejula : EPAR - Medicine overview (PDF/115.64 KB)
First published: 27/11/2017
Last updated: 06/11/2020
Zejula : EPAR - Risk-management-plan summary (PDF/360.84 KB)
First published: 10/06/2020
Last updated: 13/02/2023
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Niraparib (tosilate monohydrate)
|International non-proprietary name (INN) or common name||
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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.
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.
GlaxoSmithKline (Ireland) Limited
|Date of issue of marketing authorisation valid throughout the European Union||
15/12/2022 Zejula - EMEA/H/C/004249 - II/0033
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
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.