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ZYTIGA Film-coated tablet (2019)

Active ingredients: Abiraterone

Product name and form

ZYTIGA 500 mg film-coated tablets.

Pharmaceutical Form

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.

Qualitative and quantitative composition

Each film-coated tablet contains 500 mg of abiraterone acetate.

Excipients with known effect: Each film-coated tablet contains 253.2 mg of lactose and 13.5 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

Tablet core:

Microcrystalline cellulose (silicified)
Croscarmellose sodium
Hypromellose 2910 (15 mPa.S)
Lactose monohydrate
Magnesium stearate
Colloidal anhydrous silica
Sodium laurilsulfate

Film-coat:

Iron oxide black (E172)
Iron oxide red (E172)
Macrogol 3350
Polyvinyl alcohol
Talc
Titanium dioxide

Pack sizes and marketing

PVdC/PE/PVC/aluminum blister of 14 film-coated tablets in a cardboard wallet. Each carton contains (56 film-coated tablets) 4 wallets.

PVdC/PE/PVC/aluminum blister of 12 film-coated tablets in a cardboard wallet. Each carton contains (60 film-coated tablets) 5 wallets.

Marketing Authorization Holder
Authorization Dates

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

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

Marketing authorization number:

EU/1/11/714/002 – 56 film-coated tablets (4 wallet packs of 14)
EU/1/11/714/003 – 60 film-coated tablets (5 wallet packs of 12)

Drugs

Drug
Countries
ZYTIGA
Austria, Australia, Canada, Cyprus, Spain, France, Lithuania, Netherlands, Singapore, United Kingdom, United States