Примери за използване на Benefit-risk balance на Английски и техните преводи на Български
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Evaluation of the benefit-risk balance.
The benefit-risk balance may be found in module 6 of this EPAR.
Overall conclusion and benefit-risk balance.
The benefit-risk balance may be found in module 6 of this EPAR.
European Medicines Agency confirms positive benefit-risk balance of RotaTeq.
The benefit-risk balance may be found in module 6 of this EPAR.
The MAH considered that the data described in this PSUR did not change the benefit-risk balance of Leflunomide Apotex.
(a) the benefit-risk balance of the veterinary medicinal product is unfavourable;
This examination should include a re-assessment of the benefit-risk balance in the individual patient.
The benefit-risk balance of the veterinary medicinal product is no longer positive;
Use of letermovir prophylaxis for greater than 100 days requires a careful assessment of the benefit-risk balance.
The benefit-risk balance is considered positive for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.
Therefore, at the time of the withdrawal, the CHMP could not conclude on the benefit-risk balance of Aflunov.
The benefit-risk balance for fusafungine-containing medicines is therefore negative for all currently authorised uses.
During the mutual recognition procedure some Members States considered that the benefit-risk balance for the 60 mg dose was not positive.
The benefit-risk balance of sildenafil has not been established in patients assessed to be at WHO functional class I pulmonary arterial hypertension.
There were concerns on the impact of the results of this study on the benefit-risk balance of somatropin-containing medicinal products.
The Committee also concluded that the benefit-risk balance of tolperisone-containing parenteral formulations is not positive, and recommends the revocation of the corresponding marketing authorisations.
The French medicines agency therefore asked the CHMP to carry out an assessment of the benefit-risk balance in all populations, especially in children and the elderly.
(11)‘benefit-risk balance' means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the following risks relating to the use of that product.
Pharmacovigilance The Applicant/MAH commits to establish the mechanisms to promptly investigate issues affecting the benefit-risk balance of the vaccine.
European Medicines Agency confirms positive benefit-risk balance of Protelos/ Osseor, but recommends new contraindications and revised warnings.
This type of referral is used when it is of‘Community interest'(forthe benefit of all Member States) to have a common view on the benefit-risk balance of a medicine.
Veterinarians should assess the benefit-risk balance before vaccinating dogs in areas with little or no Leishmania infantum.
The MAH should provide an inventory of all valuable database ready to be use to promptly investigate issues affecting the benefit-risk balance of the vaccine.
European Medicines Agency confirms positive benefit-risk balance of Protelos/Osseor, but recommends new contraindications and revised warnings[press release].
Combinations of antimicrobial substances should therefore only be authorised where evidence is provided that the benefit-risk balance of the combination is favourable.
The vaccine's effect. Veterinarians should assess the benefit-risk balance before vaccinating dogs in areas with little or no Leishmania infantum.
Although efficacy of alemtuzumab in RRMS patients is well established, these emerging andserious safety concerns may impact the benefit-risk balance of Lemtrada.
The CHMP, as a consequence, considers that the benefit-risk balance of metformin containing products remains favourable subject to the amendments to the product information.