Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
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. |
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 |
Round white HDPE bottles fitted with a polypropylene child-resistant closure containing 120 tablets.
Each pack contains one bottle.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/11/714/001
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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