6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

 Lactose monohydrate

Cellulose, microcrystalline

Croscarmellose sodium

Povidone (K29/K32)

Sodium laurilsulfate

Magnesium stearate

Silica, colloidal anhydrous

6.2 Incompatibilities

 Not applicable.

6.3 Shelf life

 2 years

6.4 Special precautions for storage

 Store below 30°C.

6.5 Nature and contents of container

 Round white HDPE bottles fitted with a polypropylene cap containing 120 tablets. Each pack contains one bottle.

6.6 Special precautions for disposal and other handling

 Based on its mechanism of action, ZYTIGA may harm a developing foetus; therefore, women who are pregnant or may be pregnant should not handle ZYTIGA without protection, e.g., gloves.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

 Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

8. MARKETING AUTHORISATION NUMBER(S)

 EU/1/11/714/001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 05 September 2011

10. DATE OF REVISION OF THE TEXT

 Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.