Rubraca

rucaparib

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Patient safety

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.

: Rubraca can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer.
Rubraca is available as tablets to be taken twice a day. Treatment should continue until the cancer progresses or the patient has unacceptable side effects. Treatment with Rubraca should be started no later than 8 weeks after the patient has finished their treatment with a platinum-based medicine.
For more information about using Rubraca, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Rubraca, rucaparib, blocks the activity of a family of proteins called poly(ADP-ribose) polymerases (PARPs) that help to repair damaged DNA in cells (both normal and cancer cells). In normal cells there is an alternative mechanism for repairing DNA but this alternative mechanism does not work properly in cancer cells with mutations in the BRCA genes. Therefore, when PARP proteins are blocked, the damaged DNA in these cancer cells cannot be repaired, and, as a result, the cancer cells die.

: Rubraca was investigated in a main study of 564 patients with ovarian cancer which had cleared (partially or completely) after treatment with platinum-based cancer medicines. Patients given Rubraca lived for 11 months without the disease coming back or getting worse compared with 5 months in patients given placebo (a dummy treatment).

: For the full list of side effects and restrictions with Rubraca, see the package leaflet.
The most common side effects with Rubraca (which may affect more than 1 in 5 people) include tiredness or weakness, nausea (feeling sick), vomiting, anaemia (low red blood cell counts), abdominal pain (belly ache), dysgeusia (taste disturbances), increased levels of liver enzymes in the blood (which may indicate liver damage), decreased appetite, diarrhoea and thrombocytopenia (low levels of platelets).
Women must not breastfeed during treatment with Rubraca and for at least 2 weeks after treatment.

: Rubraca has been shown to delay worsening or return of the disease in patients whose cancer had cleared partially or completely after treatment with platinum-based medicines. This benefit was seen in patients with or without the BRCA mutation. Regarding safety, side effects occur frequently but are generally not serious and are manageable with appropriate treatment. In addition, fewer liver and blood-related problems occur with Rubraca than with other existing treatments for these patients.
The European Medicines Agency decided that Rubraca’s benefits are greater than its risks and it can be authorised for use in the EU.
Rubraca was originally given ‘conditional authorisation’ because there was more evidence to come about the use of Rubraca outside maintenance treatment of patients. This use has since been restricted. The authorisation has therefore been switched from a conditional to a standard marketing authorisation.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rubraca have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Rubraca are continuously monitored. Side effects reported with Rubraca are carefully evaluated and any necessary action taken to protect patients.

: Rubraca received a conditional marketing authorisation valid throughout the EU on 24 May 2018. This was switched to a standard marketing authorisation on 9 November 2022.

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Rubraca : EPAR - Medicine overview (PDF/104.31 KB)

First published: 31/05/2018
Last updated: 24/04/2023
EMA/109273/2023
- Bulgarian
  (PDF/128.39 KB)
- Croatian
  (PDF/123.16 KB)
- Czech
  (PDF/125.67 KB)
- Danish
  (PDF/103.76 KB)
- Dutch
  (PDF/104.14 KB)
- Estonian
  (PDF/100.42 KB)
- Finnish
  (PDF/101.39 KB)
- French
  (PDF/104.69 KB)
- German
  (PDF/107.01 KB)
- Greek
  (PDF/129 KB)
- Hungarian
  (PDF/123.27 KB)
- Italian
  (PDF/102.96 KB)
- Latvian
  (PDF/131.73 KB)
- Lithuanian
  (PDF/125.7 KB)
- Maltese
  (PDF/126.54 KB)
- Polish
  (PDF/128.55 KB)
- Portuguese
  (PDF/104.27 KB)
- Romanian
  (PDF/123.64 KB)
- Slovak
  (PDF/125.12 KB)
- Slovenian
  (PDF/122.59 KB)
- Spanish
  (PDF/103.58 KB)
- Swedish
  (PDF/102.06 KB)
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Rubraca : EPAR - Risk-management-plan summary (PDF/157.52 KB)

First published: 19/02/2019
Last updated: 22/06/2023

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 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

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Rubraca : EPAR - Product Information (PDF/327.71 KB)

First published: 31/05/2018
Last updated: 22/06/2023
- Bulgarian
  (PDF/470.64 KB)
- Croatian
  (PDF/442.07 KB)
- Czech
  (PDF/434.67 KB)
- Danish
  (PDF/355.68 KB)
- Dutch
  (PDF/345.39 KB)
- Estonian
  (PDF/350.11 KB)
- Finnish
  (PDF/359.4 KB)
- French
  (PDF/355.5 KB)
- German
  (PDF/362.08 KB)
- Greek
  (PDF/551.88 KB)
- Hungarian
  (PDF/428.05 KB)
- Icelandic
  (PDF/345.09 KB)
- Italian
  (PDF/376.57 KB)
- Latvian
  (PDF/448.28 KB)
- Lithuanian
  (PDF/411.25 KB)
- Maltese
  (PDF/472.91 KB)
- Norwegian
  (PDF/338.25 KB)
- Polish
  (PDF/418.46 KB)
- Portuguese
  (PDF/344.01 KB)
- Romanian
  (PDF/466.27 KB)
- Slovak
  (PDF/380.54 KB)
- Slovenian
  (PDF/398.07 KB)
- Spanish
  (PDF/350.89 KB)
- Swedish
  (PDF/320.05 KB)

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:

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.

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Rubraca : EPAR - All Authorised presentations (PDF/20.81 KB)

First published: 31/05/2018
Last updated: 31/05/2018
- Bulgarian
  (PDF/45.15 KB)
- Croatian
  (PDF/38.98 KB)
- Czech
  (PDF/38.93 KB)
- Danish
  (PDF/22.84 KB)
- Dutch
  (PDF/23.48 KB)
- Estonian
  (PDF/23.26 KB)
- Finnish
  (PDF/22.75 KB)
- French
  (PDF/22.31 KB)
- German
  (PDF/22.89 KB)
- Greek
  (PDF/44.8 KB)
- Hungarian
  (PDF/30.54 KB)
- Icelandic
  (PDF/23.01 KB)
- Italian
  (PDF/23.5 KB)
- Latvian
  (PDF/42.22 KB)
- Lithuanian
  (PDF/41.64 KB)
- Maltese
  (PDF/38.82 KB)
- Norwegian
  (PDF/23.07 KB)
- Polish
  (PDF/32.83 KB)
- Portuguese
  (PDF/23.57 KB)
- Romanian
  (PDF/38.91 KB)
- Slovak
  (PDF/39.23 KB)
- Slovenian
  (PDF/37.92 KB)
- Spanish
  (PDF/23.69 KB)
- Swedish
  (PDF/26.67 KB)

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

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Rubraca : EPAR - Procedural steps taken and scientific information after authorisation (PDF/191.66 KB)

First published: 19/12/2018
Last updated: 22/06/2023
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Rubraca-H-C-4272-II-0029 : EPAR - Assessment report - Variation (PDF/14.42 MB)

Adopted

First published: 25/11/2022
EMA/883431/2022
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Rubraca-H-A-20-1518-C-4272-0033 : Assessment report (PDF/1.08 MB)

Adopted

First published: 09/11/2022
EMA/674344/2022
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Rubraca : EPAR - Scientific conclusions Annex IV (PDF/734.52 KB)

First published: 09/11/2022
- Bulgarian
  (PDF/1.32 MB)
- Croatian
  (PDF/758.94 KB)
- Czech
  (PDF/744.56 KB)
- Danish
  (PDF/714.84 KB)
- Dutch
  (PDF/719.83 KB)
- Estonian
  (PDF/711.82 KB)
- Finnish
  (PDF/715.83 KB)
- French
  (PDF/723.28 KB)
- German
  (PDF/739.97 KB)
- Greek
  (PDF/737.75 KB)
- Hungarian
  (PDF/753.2 KB)
- Italian
  (PDF/715.12 KB)
- Latvian
  (PDF/756.77 KB)
- Lithuanian
  (PDF/756.49 KB)
- Maltese
  (PDF/772.31 KB)
- Polish
  (PDF/756.21 KB)
- Portuguese
  (PDF/727.02 KB)
- Romanian
  (PDF/755.04 KB)
- Slovak
  (PDF/738.97 KB)
- Slovenian
  (PDF/754.08 KB)
- Spanish
  (PDF/725.5 KB)
- Swedish
  (PDF/728.75 KB)
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Rubraca-H-C-PSUSA-00010694-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/161.7 KB)

Adopted

First published: 20/09/2021
EMA/526847/2021
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Rubraca : Orphan designation withdrawal assessment report (post-authorisation) (PDF/279.87 KB)

Adopted

First published: 19/02/2019
EMA/22653/2019
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Rubraca-H-C-4272-II-0001 : EPAR - Assessment report - Variation (PDF/5.56 MB)

Adopted

First published: 19/02/2019
EMA/902679/2019
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CHMP post-authorisation summary of positive opinion for Rubraca (II-01) (PDF/67.93 KB)

Adopted

First published: 14/12/2018
EMA/CHMP/830894/2018

Initial marketing-authorisation documents

Patient Safety

EMA recommends restricting use of cancer medicine Rubraca

22/07/2022

Rubraca

Table of contents

Overview

Rubraca : EPAR - Medicine overview (PDF/104.31 KB)

Rubraca : EPAR - Risk-management-plan summary (PDF/157.52 KB)

Authorisation details

Product information

Rubraca : EPAR - Product Information (PDF/327.71 KB)

Rubraca : EPAR - All Authorised presentations (PDF/20.81 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Rubraca : EPAR - Procedural steps taken and scientific information after authorisation (PDF/191.66 KB)

Rubraca-H-C-4272-II-0029 : EPAR - Assessment report - Variation (PDF/14.42 MB)

Rubraca-H-A-20-1518-C-4272-0033 : Assessment report (PDF/1.08 MB)

Rubraca : EPAR - Scientific conclusions Annex IV (PDF/734.52 KB)

Rubraca-H-C-PSUSA-00010694-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/161.7 KB)

Rubraca : Orphan designation withdrawal assessment report (post-authorisation) (PDF/279.87 KB)

Rubraca-H-C-4272-II-0001 : EPAR - Assessment report - Variation (PDF/5.56 MB)

CHMP post-authorisation summary of positive opinion for Rubraca (II-01) (PDF/67.93 KB)

Initial marketing-authorisation documents

Rubraca : Orphan designation withdrawal assessment report (initial authorisation) (PDF/154.11 KB)

Rubraca : EPAR - Public assessment report (PDF/5.97 MB)

CHMP summary of positive opinion for Rubraca (PDF/69.44 KB)

Patient Safety

News

More information on Rubraca

Direct healthcare professional communications (DHPC)

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