RUBRACA Film-coated tablet Ref.[7613] Active ingredients: Rucaparib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Clovis Oncology Ireland Ltd., Regus Dublin Airport, Skybridge House Dublin Airport, Swords, County Dublin, K67 P6K2, Ireland

Product name and form

Rubraca 200 mg film-coated tablets.

Rubraca 250 mg film-coated tablets.

Rubraca 300 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Rubraca 200 mg film-coated tablet: Blue, 11 mm, round film-coated tablet, debossed with “C2”.

Rubraca 250 mg film-coated tablet: White, 11 × 15 mm, diamond-shaped film-coated tablet, debossed with “C25”.

Rubraca 300 mg film-coated tablet: Yellow, 8 × 16 mm, oval film-coated tablet, debossed with “C3”.

Qualitative and quantitative composition

Rubraca 200 mg film-coated tablets: Each tablet contains rucaparib camsylate corresponding to 200 mg rucaparib.

Rubraca 250 mg film-coated tablets: Each tablet contains rucaparib camsylate corresponding to 250 mg rucaparib.

Rubraca 300 mg film-coated tablets: Each tablet contains rucaparib camsylate corresponding to 300 mg rucaparib.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rucaparib

Rucaparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair. In vitro studies have shown that rucaparibinduced cytotoxicity involves inhibition of PARP enzymatic activity and the trapping of PARP-DNA complexes resulting in increased DNA damage, apoptosis, and cell death.

List of Excipients

Tablet core:

Microcrystalline cellulose
Sodium starch glycolate (Type A)
Colloidal anhydrous silica
Magnesium stearate

Rubraca 200 mg film-coated tablets

Tablet coating:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 4000 (E1521)
Talc (E553b)
Brilliant blue FCF aluminium lake (E133)
Indigo carmine aluminium lake (E132)

Rubraca 250 mg film-coated tablets

Tablet coating:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 4000 (E1521)
Talc (E553b)

Rubraca 300 mg film-coated tablets

Tablet coating:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 4000 (E1521)
Talc (E553b)
Iron oxide yellow (E172)

Pack sizes and marketing

HDPE bottle, with a polypropylene (PP) induction seal closure, containing 60 tablets. Each carton contains one bottle.

Marketing authorization holder

Clovis Oncology Ireland Ltd., Regus Dublin Airport, Skybridge House – Dublin Airport, Swords, County Dublin, K67 P6K2, Ireland

Marketing authorization dates and numbers

EU/1/17/1250/001
EU/1/17/1250/002
EU/1/17/1250/003

Date of first authorisation: 24 May 2018
Date of latest renewal: 13 March 2019

Drugs

Drug Countries
RUBRACA Austria, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, United Kingdom, United States

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