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ZYTIGA (2013)

Active ingredients: Abiraterone

Product Name and Form

ZYTIGA 250 mg tablets.

Pharmaceutical form

Tablet.

White to off-white oval tablets, debossed with AA250 on one side.

Qualitative and Quantitative Composition

Each tablet contains 250 mg of abiraterone acetate.

Excipients with known effect: Each tablet contains 189 mg of lactose and 6.8 mg of sodium.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Abiraterone

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.

List of excipients

Cellulose, microcrystalline
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Povidone (K29/K32)
Silica, colloidal anhydrous
Sodium laurilsulfate

Pack sizes and Marketing

Round white HDPE bottles fitted with a polypropylene child-resistant closure containing 120 tablets. Each pack contains one bottle.

Marketing authorization holder
Authorization dates

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340
Beerse
Belgium

Date of first authorisation: 5 September 2011

Marketing authorization number:

EU/1/11/714/001