United States - English - NLM (National Library of Medicine)

tesaro, inc. - niraparib (unii: hmc2h89n35) (niraparib - unii:hmc2h89n35) - niraparib 100 mg - zejula® is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. zejula® is indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either: - a deleterious or suspected deleterious brca mutation, or - genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy [see clinical studies (14.2)] . select patients for therapy based on an fda-approved companion diagnostic for zejula. none. risk summary based on its mechanism of action, zejula can cause fetal harm when administered to pregnant women [see clinical pharmacology (12.1)] . there are no data regarding the use

Canada - English - Health Canada

glaxosmithkline inc - niraparib (niraparib tosylate) - capsule - 100mg - niraparib (niraparib tosylate) 100mg - antineoplastic agents

Canada - English - Health Canada

glaxosmithkline inc - niraparib (niraparib tosylate) - tablet - 100mg - niraparib (niraparib tosylate) 100mg

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - niraparib tosylate monohydrate eqv niraparib - tablet, film coated - niraparib tosylate monohydrate eqv niraparib 100mg

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - niraparib tosylate monohydrate eqv niraparib - tablet, film coated - niraparib tosylate monohydrate eqv niraparib 200mg

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - niraparib tosylate monohydrate eqv niraparib - tablet, film coated - niraparib tosylate monohydrate eqv niraparib 300mg

Canada - English - Health Canada

janssen inc - niraparib (niraparib tosylate); abiraterone acetate - tablet - 50mg; 500mg - niraparib (niraparib tosylate) 50mg; abiraterone acetate 500mg

Canada - English - Health Canada

janssen inc - niraparib (niraparib tosylate); abiraterone acetate - tablet - 100mg; 500mg - niraparib (niraparib tosylate) 100mg; abiraterone acetate 500mg

Israel - English - Ministry of Health

medison pharma ltd - niraparib as tosylate monohydrate - hard capsule - niraparib as tosylate monohydrate 100 mg - niraparib - 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.• 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.

Israel - English - Ministry of Health

medison pharma ltd - niraparib as tosylate monohydrate - hard capsule - niraparib as tosylate monohydrate 100 mg - niraparib - zejula is indicated as monotherapy for the maintenance treatment of adult patients with 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.• 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.