Примери за използване на Proposed indication на Английски и техните преводи на Български
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Therefore, the CVMP concluded that the proposed indication was justified.
The proposed indication for Gutal is for the prevention of postweaning diarrhoea in piglets.
These results can be considered sufficient to support the proposed indication.
The CHMP noted the proposed indication“skin and soft tissue infections”(SSTI).
As a consequence, children with autistic disorders are not included in the proposed indication.
The proposed indication is‘pain relief of mild to moderate symptoms of acute sore throat'.
Therefore, the CHMP agreed with the following proposed indication for 4mg chewable tablets.
The CHMP noted the proposed indication“bone and joint infections” but considered the data submitted to be insufficient.
The two clinical studies initially submitted by the MAH to support the proposed indication were.
Thus the demonstrated benefit for patients in the proposed indication does not outweigh the above identified risk.
The benefit-risk balance for Fiprex remains inconclusive in the absence of adequate data to justify the proposed indications.
These studies support the proposed indication for the symptomatic treatment of rhinitis(seasonal allergic and perennial) in adults.
The Committee considered that the benefit risk balance of the product in the proposed indication is not positive.
Furthermore, the proposed indication was not supported by the provided literature, and the target population was considered not sufficiently characterised.
Therefore, at the time of the withdrawal,the CHMP was of the opinion that the benefits of Elmisol in the proposed indication did not outweigh its risks.
The Committee considered that the proposed indication“treatment of respiratory tract infections caused by M. haemolytica” had been sufficiently substantiated by data.
The Committee concluded to maintain its previous opinion that the benefit-risk balance of this medicinal product is negative for both proposed indications.
Taking into account the scope of this Article 34 referral procedure, the proposed indication for L. intracellularis in pigs was deemed acceptable.
The MAH agreed to withdraw the indication SSTI andtonsillopharyngitis, as well as the initially proposed indication UTI.
In horses, the proposed indications are for the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders and for the relief of pain associated with equine colic.
Therefore the CHMP is of the opinion that bleomycin is still a valuable chemotherapeutic drug, andadopted the totality of the proposed indications, for Bleomycin Pharmachemie.
The proposed indication was‘Treatment of colibacillosis caused by Escherichia coli and not zoonotic Salmonella(Salmonella Pullorum and Salmonella Gallinarum) susceptible to apramycin'.
The Committee concluded that in the absence of demonstrationof efficacy for Alcover granules in sachets, the benefit-risk balance of this medicinal product is not favourable in the proposed indications.
The proposed indications are a range of diseases including deep and superficial pyoderma, soft tissue infections, dental infections, urinary tract infections, respiratory disease and enteritis in dogs and cats.
Potential serious risks were identified during the decentralised procedure bytwo concerned Member States, by France regarding the proposed indications and by Denmark regarding the efficacy of the product.
The UK considered that the efficacy of Seresto for the proposed indication has not been sufficiently demonstrated and that accepting the indication could pose a serious risk to animal and human health.
The treatment of CMV disease in stem cell transplant(SCT) and solid organ transplant(SOT) recipient is recommended by guidelines,the data supporting the proposed indication are obtained from published literature.
The MAH to support this proposed indication presented two randomised, placebo controlled studies(HS230027 and HS0028)[Spruance, 2003] evaluating the efficacy and safety of one dosing regimen of VACV, 2000 mg twice daily for 1 day, compared to placebo.
The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergotoxine in the proposed indication“symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia” is very limited.
The proposed indication is: symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers who are adequately controlled with diclofenac and omeprazole.