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
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”. |
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 Rubraca 200 mg film-coated tablets Tablet coating: Polyvinyl alcohol (E1203) Rubraca 250 mg film-coated tablets Tablet coating: Polyvinyl alcohol (E1203) Rubraca 300 mg film-coated tablets Tablet coating: Polyvinyl alcohol (E1203) |
HDPE bottle, with a polypropylene (PP) induction seal closure, containing 60 tablets. Each carton contains one bottle.
Clovis Oncology Ireland Ltd., Regus Dublin Airport, Skybridge House – Dublin Airport, Swords, County Dublin, K67 P6K2, Ireland
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
| Drug | Countries | |
|---|---|---|
| RUBRACA | Austria, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, United Kingdom, United States |
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