Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
ZYTIGA 500 mg film-coated tablets.
| Pharmaceutical Form |
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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. |
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 |
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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 |
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Tablet core: Microcrystalline cellulose (silicified) Film-coat: Iron oxide black (E172) |
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.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
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)
Date of first authorisation: 05 September 2011
Date of latest renewal: 26 May 2016
| 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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