Примери за използване на Proposed indication на Английски и техните преводи на Български
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The Committee concluded to maintain its previous opinion that the benefit-risk balance of this medicinal product is negative for both proposed indications.
The benefit-risk balance for Fiprex remains inconclusive in the absence of adequate data to justify the proposed indications.
two concerned Member States, by France regarding the proposed indications and by Denmark regarding the efficacy of the product.
risks of the generic medicine in the proposed indications.
In conclusion, the CHMP considered that the available evidence does not support the proposed indications in"allergic and idiopathic rhinitis,
It is clear that there are very limited scientific data available to support many of the proposed indications for use of the product,
the existing clinical evidence, the proposed indications are considered appropriate;
are adequate to support its positive benefit/risk balance in the proposed indications.
The use of FDG PET-CT has been reported in all of the 10 proposed indications in‘Infectious or inflammatory diseases',
The product is used in the proposed indications(swine dysentery
The proposed indications for STRENZEN 500/125 mg/g powder for use in drinking water for pigs are treatment of respiratory tract infections caused by microorganisms susceptible to the combination amoxicillin/clavulanic acid i.e. Actinobacillus pleuropneumoniae,
withdrawal in the light of the proposed indications;
safety of Symbioflor 2 in their proposed indications and sought as well views of the ad hoc expert group on Symbioflor 2;
The proposed indication is short-term symptomatic relief of sore throat.
Therefore the CHMP agreed to the proposed indication in CRPC intended specifically for palliation.
The proposed indication by the applicant for Valebo was the“Treatment of postmenopausal osteoporosis.
The MAH's proposed indication wording for nephritic syndrome is approved in 16 EU countries.
The MAH's proposed indication wording for rheumatoid arthritis is approved in 13 EU countries.
Thus, the benefit/risk assessment is deemed unfavourable for the proposed indication in cats.
The MAH's proposed indication wording for the uveitis and Behçet uveitis is approved in 14 EU countries.