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 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.
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List item
Rubraca : EPAR - Medicine overview (PDF/104.31 KB)
First published: 31/05/2018
Last updated: 24/04/2023
EMA/109273/2023 -
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Rubraca : EPAR - Risk-management-plan summary (PDF/157.52 KB)
First published: 19/02/2019
Last updated: 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 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 | |
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Marketing-authorisation holder |
zr pharma & GmbH
|
Revision |
13
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Date of issue of marketing authorisation valid throughout the European Union |
23/05/2018
|
Contact address |
zr pharma & GmbH |
Product information
08/06/2023 Rubraca - EMEA/H/C/004272 - T/0040, II/0037
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.