ZYTIGA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug ZYTIGA contains one active pharmaceutical ingredient (API):

1 Abiraterone UNII EM5OCB9YJ6 - ABIRATERONE ACETATE

Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor. Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues. CYP17 inhibition also results in increased mineralocorticoid production by the adrenals. Read about Abiraterone

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ZYTIGA Film-coated tablet	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC
ZYTIGA Tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L02BX03	Abiraterone	L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents → L02BX Other hormone antagonists and related agents
Discover more medicines within L02BX03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11206T, 2698B
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 514512020025102, 514519020035403
Country: CA	Health Products and Food Branch	Identifier(s): 02371065, 02457113
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): H2931212
Country: EE	Ravimiamet	Identifier(s): 1539547, 1734757, 1734768
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 111714003
Country: FR	Base de données publique des médicaments	Identifier(s): 67337081
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 340657, 383807
Country: HK	Department of Health Drug Office	Identifier(s): 61370, 65540
Country: IE	Health Products Regulatory Authority	Identifier(s): 88019
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6934
Country: IT	Agenzia del Farmaco	Identifier(s): 041427016, 041427028, 041427030
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291033F1024, 42910G0F1025
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1061975, 1082037, 1082038
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 241M2012
Country: NG	Registered Drug Product Database	Identifier(s): B4-8220
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 100846, 136913
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 15590, 18307
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100253258, 100380956
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W58139001, W63682001, W63682002
Country: SG	Health Sciences Authority	Identifier(s): 14146P, 15345P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 15273021H, 15273022H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699593015304, 8699593095450
Country: US	FDA, National Drug Code	Identifier(s): 57894-150, 57894-195
Country: ZA	Health Products Regulatory Authority	Identifier(s): 46/21.12/0379, 52/21.12/0284