Is Rucaparib camsylate approved by the US FDA?

Drugs@FDA lists 1 application product line for Rucaparib camsylate, including RUBRACA (Prescription).

Is Rucaparib camsylate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Rucaparib camsylate: Rubraca.

Are there safety signals or safety updates for Rucaparib camsylate?

US FDA: 1 entry (latest 2025-12-17).

Active substance

Rucaparib camsylate

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
RUBRACA	EQ 200MG BASE; EQ 300MG BASE; EQ 250MG BASE	tablet · oral	PHARMAAND	Prescription	19 Dec 2016

EMA European Union — centrally authorised medicines

Rubraca pharmaand GmbH · Authorised · authorised 23 May 2018 · ATC L01XX

Therapeutic indication (EMA)

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. 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.

Safety signals and safety-related labeling changes

US FDA 17 Dec 2025 RUBRACA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for rucaparib camsylate →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.