European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastic agents - 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.

Canada - English - Health Canada

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

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

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

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.