Примери за използване на Risk-benefit balance на Английски и техните преводи на Български
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pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable
pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable
to permit a reassessment to be made at any time of the risk-benefit balance of a medicinal product.
took the view that the risk-benefit balance of the product is not positive under normal conditions of use.
that it lacks therapeutic efficacy, or that the risk-benefit balance is not favourable, or that its qualitative
to detect any change in the risk-benefit balance.";
the risk minimisation measures, the CHMP considered that the risk-benefit balance of buflomedil-containing medicinal products is not positive under normal conditions of use.
information relating to ongoing risk-benefit balance evaluations regarding the use of a veterinary medicinal product in specified animal species,
it should be possible to assess the risk-benefit balance of all medicinal products when they are placed on the market,
covering the efficacy of the vaccines, their risk-benefit balance and the different target groups recommended, with regard to a safe
(b)the risk-benefit balance of the veterinary medicinal product is unfavourable;
Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
(2) the holder of the authorisation shall notify the FDA any new information which might influence the risk-benefit balance of the medicinal product.
Risk-benefit balance An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in point 28(Dir 2004/27/EC), first indent.
efficacy of cefuroximaxetil in uncomplicated gonorrhoea and to conclude on the risk-benefit balance for this sought indication.
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
Lt; The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.>
Marketing authorisation under exceptional circumstances The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
detect changes to their risk-benefit balance.