This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 14/01/2021

Authorisation details

Product details
Agency product number
Active substance
rucaparib camsylate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional 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.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Clovis Oncology Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Regus Dublin Airport
Skybridge House - Dublin Airport
County Dublin
K67 P6K2

Product information

17/12/2020 Rubraca - EMEA/H/C/004272 - II/0020


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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.

Assessment history

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