Member of Farmavita.Net offers transfer of marekting atuhorisation for generic EU CTD Dossier for Simvastatin, tablets 5-10-20-40-80 mg.
Offer is valid subject to confirmation, country by country. Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.
Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol.
In patients with CHD or at high risk of CHD, Simvastatin can be started simultaneously with diet.
Epidemiological studies have demonstrated that elevated levels of total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), as well as decreased levels of high-density lipoprotein cholesterol (HDL-C) are associated with the development of atherosclerosis and increased cardiovascular risk. Lowering LDL-C decreases this risk. However, the independent effect of raising HDL-C or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.
More info at http://www.rxlist.com/cgi/generic/simva.htm
|Pharma licensing||Out-licensing (offer)|