Примери за използване на Post-marketing data на Английски и техните преводи на Български
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frequency categories for those reactions identified from post-marketing data to take into account the revised SPC guidelines.
After evaluating data from studies and post-marketing data from outside the EU,
The committee reviewed the data submitted by the MAH on clinical studies, post-marketing data and published literature justifying the proposed harmonisation of the product information.
atazanavir boosted with either cobicistat or ritonavir, and post-marketing data.
published studies and post-marketing data;
Review of post-marketing data suggests that patients aged 65 years or older report a
Review of post-marketing data suggests that patients aged 65 years
meta-analyses, post-marketing data and further published data. .
The table with adverse reactions from clinical trials and post-marketing data for both adult and paediatric subjects together, in line with the current table of adverse reactions in the Core Safety Profile(CSP) was proposed.
Based on human experience, post-marketing data suggest that use of fingolimod is associated with a 2-fold increased risk of major congenital malformations when administered during pregnancy compared with the rate observed in the general population(2-3%; EUROCAT).
meta-analyses, post-marketing data and further published data on the cardiovascular risks associated with testosterone therapy.
The available clinical studies on both these indications were presented by the MAH together with post-marketing data and published literature
from cobicistat and from post-marketing data from darunavir/ritonavir.
which considered post-marketing data and published studies,
metaanalyses, post-marketing data and further published literature data on the use of codeine containing products in children for treatment of cough and/or cold.
Post-marketing data from an additional 250 outcomes from pregnant women exposed to Levemir indicate no adverse effects of insulin detemir on pregnancy
This potential risk was confirmed by clinical and post-marketing data, which also identified the at-risk population as consisting of patients with risk factors for QT interval prolongation,
Post-marketing data In addition to the adverse reactions identified from clinical trial data,
Clinical trial data and post-marketing data Table 3 presents adverse reactions by system organ class
A cumulative review of post-marketing data revealed that there were a total of 17 cases where the reporter described organising pneumonia associated with daptomycin therapy without reporting an associated diagnosis of pulmonary eosinophilia or eosinophilic pneumonia.