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Gestational diabetes

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GSK Applies For E.U. Approval Of Late-Stage Breast Cancer Drug Tykerb
GlaxoSmithKline on Monday announced that it has filed an application with the European Medicines Agency to sell its experimental breast cancer drug Tykerb in combination with Roche's chemotherapy drug Xeloda in the European Union, the

GPhA, FDA To Focus On Science And Regulatory Issues For The Generic Pharmaceutical Industry At 2006 Fall Technical Conference
Wed.-Thu., October 18-19, Bethesda Marriott North, Bethesda, Maryland.Current and future scientific and regulatory issues for the generic pharmaceutical industry will be the focus of the Generic Pharmaceutical Association's (GPhA) Fall Technical Conference on October 18-19, 2006.

La Jolla Limited Withdraws Its Marketing Authorisation Application For Riquent To Treat Lupus Nuphritis
The European Medicines Agency has been formally notified by La Jolla Limited of its decision to withdraw its application for a centralised marketing authorisation for the medicinal product Riquent (abetimus sodium).Riquent was expected to be used to treat lupus nephritis, an inflammation of the kidneys, in patients with systemic lupus erythematosus (an auto-immune disease caused by the body's own defence system attacking normal tissue) who have a history of kidney disease.

Novo Nordisk Withdraws Its Application To Extend The Marketing Authorisations For NovoNorm And Prandin
The European Medicines Agency has been formally notified by Novo Nordisk A/S of its decision to withdraw its application for a change to the marketing authorisations for NovoNorm (repaglinide) and Prandin (repaglinide) 0.5 mg, 1 mg and 2 mg tablets. NovoNorm was first authorised in the European Union on 17 August 1998 and Prandin on 29 January 2001. Both products are currently indicated for use in patients who have non-insulin-dependent diabetes (type-2 diabetes).

FDA To Expedite Reviews Of Some Generic Drugs, Official Says
FDA will accelerate reviews for certain generic medications, Steven Galson, director of the agency Center for Drug Evaluation and Research, said on Wednesday, Reuters/Los Angeles Times reports.

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