ZYTIGA

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

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 more about Abiraterone

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-100495	Tablet	Zytiga 500 mg Tablet TAB 500 mg 5 x 12's (in PVdC/PE/PVC/aluminium blisters)	Film-coated tablet. Purple, oval-shaped, film-coated tablets (20 mm long by 10 mm wide), debossed with “AA” on one side and “500” on the other side	27/07/2023
B4-8220	Tablet	Zytiga 250mg Tablets TAB 250 mg 1 x 120's (in HDPE bottle)	Tablet. White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed with AA250 on one side	28/03/2023

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	11206T, 2698B
BR	Câmara de Regulação do Mercado de Medicamentos	514512020025102, 514519020035403
CA	Health Products and Food Branch	02371065, 02457113
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	H2931212
EE	Ravimiamet	1539547, 1734757, 1734768
ES	Centro de información online de medicamentos de la AEMPS	111714003
FR	Base de données publique des médicaments	67337081
GB	Medicines & Healthcare Products Regulatory Agency	340657, 383807
HK	Department of Health Drug Office	61370, 65540
IE	Health Products Regulatory Authority	88019
IL	מִשְׂרַד הַבְּרִיאוּת	6934
IT	Agenzia del Farmaco	041427016, 041427028, 041427030
JP	医薬品医療機器総合機構	4291033F1024, 42910G0F1025
LT	Valstybinė vaistų kontrolės tarnyba	1061975, 1082037, 1082038
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	241M2012
NG	Registered Drug Product Database	A4-100495, B4-8220
NL	Z-Index G-Standaard, PRK	100846, 136913
NZ	Medicines and Medical Devices Safety Authority	15590, 18307
PL	Rejestru Produktów Leczniczych	100253258, 100380956
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W58139001, W63682001, W63682002
SG	Health Sciences Authority	14146P, 15345P
TN	Direction de la Pharmacie et du Médicament	15273021H, 15273022H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593015304, 8699593095450
US	FDA, National Drug Code	57894-150, 57894-195
ZA	Health Products Regulatory Authority	46/21.12/0379, 52/21.12/0284