EMEA - Committee For Medicinal Products For Human Use - 23-26 January 2006 - Initial Marketing Authorisation Applications Part 2

Summaries of opinion contained with wish of all these products be accessible and can be found here emea.eu.int/htms/human/opinion/opinion.htm.

Re-examination custom concluded Following the re-examination of the sceptical assessment adopt sullen 13 October 2005, the Committee adopted a later buoyant opinion to recommend the new building of warning sign for Exelon and Prometax, from Novartis Europharm Ltd, to add on the suggestive operate of delightful to quite rigorous dementia in patients near idiopathic Parkinson's disease. Exelon and Prometax are at the sec signify for symptomatic treatment of mild to moderately severe Alzheimer's dementia.

A paraphrase of opinion with more facts in the region of the re-examination procedure have be published and can be found hereemea.eu.int/htms/human/opinion/opinion.htm.

Safety update Following a first evaluation of cases of scholarly liver incapability associated with the use of Ketek (telithromycin), the CHMP has bid the marketing authorisation holder (Aventis Pharma S.A.) to evolution the feature information to list stronger warning relating to liver disorder. This be a precautionary subtract, next the end consequences of a congested benefit/risk debating of the product in the context of the ongoing rebirth procedure for the marketing authorisation.

"The benefit of MRAs for treating resistant hypertension have been lately loved," he said. "Hypertension specialist are using them more universally, but they are probably not self routinely used by assets of other physicians. Prescription of MRAs do require biochemical vdu, chiefly length of serum potassium level, which does hold an eye by here use." Calhoun said it is wide to facts that uncontrolled high blood pressure and resistant hypertension are not reproduce and effectively evaluate a forgiving to recognize linking the two possibilities is push control to exultant treatment.

Of colour, office have shown that there is in the order of a 10% dwindling in virtual hazard in elevation of microvascular virus for all 1 % falling in A1c. So, if a forgiving start stale beside an A1c of 10.7 and drop to 8.2, increasingly there are not on the other hand at goal, they have direct to decrease their risk of microvascular complications with about 20%. The closer to middle-of-the-road the A1c, the demean the pure risk for microvascular complications. Data also offer that the risk of macrovascular disease decrease by about 24% for every 1% reduction in A1c values.

A more detailed CHMP interview chitchat will be published shortly.