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

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

Canada - English - Health Canada

astrazeneca canada inc - olaparib - tablet - 100mg - olaparib 100mg - antineoplastic agents

Canada - English - Health Canada

astrazeneca canada inc - olaparib - tablet - 150mg - olaparib 150mg - antineoplastic agents

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

janssen biotech, inc. - niraparib tosylate monohydrate (unii: 195q483uzd) (niraparib - unii:hmc2h89n35), abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - akeega with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious brca -mutated ( brca m) metastatic castration-resistant prostate cancer (mcrpc). select patients for therapy based on an fda-approved test for akeega [see dosage and administration (2.1)] . none. risk summary the safety and efficacy of akeega have not been established in females. based on findings from animal studies and mechanism of action [see clinical pharmacology (12.1)] , akeega can cause fetal harm and potential loss of pregnancy. there are no human data on the use of akeega in pregnant women. niraparib has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow) [see warnings and precautions (5.2)and nonclinical toxicology (13.1)] . due to the potential risk to a fetus based on its mechanism of action, animal developme

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - niraparib tosilate monohydrate, quantity: 159.3 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; povidone; crospovidone; silicon dioxide; magnesium stearate; polyvinyl alcohol; titanium dioxide; macrogol 4000; purified talc; ferrosoferric oxide - zejula is indicated:,- for the maintenance treatment of adult patients with advanced 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.

Canada - English - Health Canada

astrazeneca canada inc - olaparib - capsule - 50mg - olaparib 50mg - antineoplastic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

tesaro uk ltd - niraparib tosylate monohydrate - capsule - 100mg