Rubraca (rucaparib)
- Region
- 🇪🇺 EU
- Active substance
- rucaparib
- Company
- pharmaand GmbH
- Status
- Authorised
- Therapeutic area
- Ovarian Neoplasms
- CHMP opinion
- Mon 06 Nov 2017
- EU approval
- Wed 23 May 2018
- Application
- EMEA/H/C/004272
- ATC
- L01XX
- Official record
- www.ema.europa.eu
Indication
Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade 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.
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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.