ZYTIGA Tablet Ref.[28092] Active ingredients: Abiraterone

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

ZYTIGA 250 mg tablets.

Pharmaceutical Form

Tablet.

White to off-white oval tablets (15.9 mm long x 9.5 mm wide), 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.

Active Ingredient 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

Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Povidone (K29/K32)
Colloidal anhydrous silica
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

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

Marketing authorization dates and numbers

EU/1/11/714/001

Date of first authorisation: 05 September 2011
Date of latest renewal: 26 May 2016

Drugs

Drug Countries
ZYTIGA 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

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