m reproductive organ changes seen in all animal toxicology studies, non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Carcinogenicity studies were not conducted.
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. |
