Примери за използване на Benfluorex на Английски и техните преводи на Български
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What is benfluorex?
Benfluorex has no action on insulin-secretion.
Medicines containing benfluorex were first authorised in 1974.
The answer: Italy and Spain did not revoke the marketing authorisation for benfluorex.
Why was benfluorex reviewed?
That have shown a risk of cardiac valve diseases and pulmonary hypertension(PHT)for patients treated with benfluorex.
Benfluorex was used as an add-on treatment in patients with diabetes who are overweight.
In Cyprus and Luxembourg,medicinal products containing benfluorex were not marketed any longer.
The scandalous case of benfluorex, known by the name of Mediator in France, is proof positive of this.
The CHMP noted that the available data show that the effect of benfluorex in the treatment of diabetes is only limited.
Benfluorex is used as an adjunct in the management of type 2 diabetes mellitus in overweight patients.
Lead to the conclusion of an existence of cardiac valvulopathy andPHT in the general population of patients using benfluorex.
The type of effect of benfluorex(valvulopathy which remains clinically asymptomatic for a long period of time);
The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended,for medicinal products containing benfluorex.
Benfluorex is used as an“Adjuvant therapy of overweight diabetics, in combination with an appropriate diet”.
Can the Commission explain why a decision was not taken in 1998 to ban the marketing of pharmaceuticals containing benfluorex?
In addition, there is risk of valve diseases with the use of benfluorex, which was confirmed in a new study conducted in October 2009.
For example, doubts still remain about possible conflicts of interest in relation to the assessment of the appetite suppressant benfluorex.
Based on the aforementioned data,the CHMP considers that the link between exposure to benfluorex and the occurrence of cardiac valve diseases is confirmed.
In March 1999, the pharmacovigilance working party concluded that there were no major benefit-risk concerns for medicinal products containing benfluorex.
The Committee concluded, after having reviewed the available data, that benfluorex is harmful under normal conditions of use leading to pulmonary hypertension and cardiac valvulopathies.
The first question was:can the Commission explain why a decision was not taken in 1998 to ban the marketing of pharmaceuticals containing benfluorex?
The Committee, in light of the above findings,concluded that the benefit/risk balance of benfluorex containing medicinal products is not favourable under the normal conditions of use.
However, the CHMP maintains the opinion that these data further confirm the safety signal of a risk of cardiac valve disorders with the use of benfluorex.
Benfluorex was discussed within the pharmacovigilance working party, acting in its role as a forum for Member States to exchange pharmacovigilance data among themselves.
Further to receipt of the Rapid Alert,the Portuguese Competent Authority also decided to suspend the marketing authorisation of all benfluorex containing medicinal products in Portugal on 30 November.
Benfluorex works by making the cells more sensitive to insulin, which means that the body makes better use of the insulin it produces and the blood glucose is reduced.
The MAH, in their written response, considers that there is a consistent significant clinical effect on blood glucose control in all the studies performed with benfluorex in overweight type 2 diabetic patients.
The committee considered that benfluorex should not be included in the scope of an ongoing evaluation procedure at European level, concerning certain anorectic agents due to a different mode of action.
In particular, this issue of independence concerns the assessment of the appetite suppressant benfluorex, the active ingredient in the product Mediator, which may have suffered from conflicts of interest.