product does not require any special temperature storage conditions.
Keep the bottle tightly closed in order to protect from moisture.
6.5 Nature and contents of container
High density polyethylene (HDPE) bottles, with a polypropylene cap and an induction seal.
Aluminium/polychlorotrifluoroethylene/PVC blister.
Pack sizes of 45, 99, 198, 270 or 297 tablets per carton.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Mitsubishi Pharma Europe Ltd.
Dashwood House
69 Old Broad Street
London
EC2M 1QS
United Kingdom
Tel: +44 (0)207 065 5000
Fax: +44 (0)207 065 5050
Email: information@mitsubishi-pharma.eu
8. Marketing authorisation number(s)
EU/1/12/804/001-010
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 21 January 2013
10. Date of revision of the text
8 August 2013
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
