Rubraca

RSS

rucaparib

Authorised
This medicine is authorised for use in the European Union.

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 is used as maintenance treatment in patients whose recurring cancer has cleared (partially or completely) after treatment with platinum-based cancer medicines.

Rubraca contains the active substance rucaparib.

This EPAR was last updated on 22/06/2023

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 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.

Publication details
Marketing-authorisation holder
zr pharma & GmbH
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
23/05/2018
Contact address

zr pharma & GmbH
Taborstrasse 1
1020 Vienna
Austria
 

Product information

08/06/2023 Rubraca - EMEA/H/C/004272 - T/0040, II/0037

Other EU languages available icon 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:

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.

Assessment history

Changes since initial authorisation of medicine

Related content

How useful was this page?

Add your rating
Average
8 ratings
3 ratings
5 ratings
2 ratings
1 rating