Opaque blisters (PVC/PE/PVDC and aluminum). Packs of 14, 28, 56, 112, 168, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) film-coated tablets. Pack of 50 x 1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

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

7. MARKETING AUTHORISATION HOLDER

 Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

 EU/1/08/455/008

EU/1/08/455/009

EU/1/08/455/010

EU/1/08/455/011

EU/1/08/455/012

EU/1/08/455/013

EU/1/08/455/014

EU/1/08/455/016

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 16 July 2008

10. DATE OF REVISION OF THE TEXT

 24 August 2011

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