Basic Information
Zejula
Regulatory Information
EMEA/H/C/004249
November 16, 2017
September 14, 2017
26
November 28, 2024
Company Information
Ireland
12 Riverwalk Citywest Business Campus Dublin 24
GLAXOSMITHKLINE (IRELAND) LIMITED
Drug Classification
Active Substances Detail
Niraparib (tosilate monohydrate)
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.