ONCOLOGY
ABIRATERON NV
Film-coated tablets
Pharmacotherapeutic group:
Antitumor hormone preparations and hormone drugs,
hormone antagonists and related compounds, other hormone antagonists and
related compounds
INN:
Abiraterone
Dosage:
250 mg
Available on a doctor's prescription
What is the drug ABIRATERONE NV
The drug ABIRATERONE NV contains the active substance
abiraterone acetate, which in the body quickly turns into abiraterone, which
suppresses the formation of male sex hormones (testosterone and other
androgens).
Indications for use
Abiraterone is
indicated for use in adult men in combination with prednisone for the treatment
of metastatic castration-resistant prostate cancer.
Packaging
120 tablets each in high-density polyethylene vials, sealed with a polypropylene lid with first-time opening control, with or without child protection.
Each bottle, along with a leaflet, is placed in a pack of cardboard.
Efficacy and safety studies
In accordance with current legislation, the drug has proven its effectiveness, safety and quality during state registration. For registration purposes, a bioequivalence study was conducted with the original (reference) medicinal product.