Rubraca
rucaparib
Table of contents
Overview
Rubraca is a cancer medicine for treating high-grade cancers of the ovary, fallopian tubes (the tubes connecting ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).
It can be used as maintenance treatment in patients whose recurring cancer has cleared (partially or completely) after treatment with platinum-based cancer medicines.
It can also be used if the patient’s cancer has returned or is worsening after two treatments with platinum-based medicines and they can no longer have these medicines. For such patients, tests for a genetic mutation (BRCA mutation) should be carried out first to see if Rubraca is likely to work for them.
Rubraca contains the active substance rucaparib.
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Rubraca : EPAR - Medicine overview (PDF/120.39 KB)
First published: 31/05/2018
Last updated: 18/12/2019
EMA/CHMP/685966/2019 -
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Rubraca : EPAR - Risk-management-plan summary (PDF/186.69 KB)
First published: 19/02/2019
Last updated: 25/11/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Rubraca
|
| Agency product number |
EMEA/H/C/004272
|
| Active substance |
rucaparib camsylate
|
| International non-proprietary name (INN) or common name |
rucaparib
|
| Therapeutic area (MeSH) |
Ovarian Neoplasms
|
| Anatomical therapeutic chemical (ATC) code |
L01XX
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Clovis Oncology Ireland Limited
|
| Revision |
11
|
| Date of issue of marketing authorisation valid throughout the European Union |
23/05/2018
|
| Contact address |
1st Floor, Building Two |
Product information
07/12/2022 Rubraca - EMEA/H/C/004272 - IAIN/0038
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
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.
Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.