Zejula (niraparib)
- Region
- 🇪🇺 EU
- Active substance
- niraparib
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
- CHMP opinion
- Thu 14 Sep 2017
- EU approval
- Thu 16 Nov 2017
- Designations
- Orphan
- Application
- EMEA/H/C/004249
- ATC
- L01XK02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Akeega Authorised ·
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.