served effect level (NOEL) was 30 mg/kg/day.
The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified.
Non-neoplastic lesions not identified in earlier preclinical studies were the cardiovascular system, pancreas, endocrine organs and teeth. The most important changes included cardiac hypertrophy and dilatation, leading to signs of cardiac insufficiency in some animals.
The active substance imatinib demonstrates an environmental risk for sediment organisms.
6. Pharmaceutical particulars
6.1 List of excipients
Tablet core:
Cellulose microcrystalline
Crospovidone
Hypromellose
Magnesium stearate
Silica, colloidal anhydrous
Tablet coat:
Iron oxide, red (E172)
Iron oxide, yellow (E172)
Macrogol
Talc
Hypromellose
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 30°C.
Store in the original package in order to protect from moisture.
6.5 Nature and contents of container
PVC/alu blisters
Glivec 100 mg film-coated tablets: Packs containing 20, 60, 120 or 180 film-coated tablets
Glivec 400 mg film-coated tablets: Packs containing 10, 30 or 90 film-coated tablets
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom
8. Marketing authorisation number(s)
Glivec 100 mg film-coated tablets:
EU/1/01/198/007
EU/1/01/198/008
EU/1/01/198/011
EU/1/01/198/012
Glivec 400 mg film-coated tablets:
EU/1/01/198/009
EU/1/01/198/010
EU/1/01/198/013
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation:
07 November 2001
Date of latest renewal:
07 November 2006
10. Date of revision of the text
24 October 2013
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
