Examples of using Efficacy data in English and their translations into Hungarian
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The efficacy data favouring the twice-daily regimen are reinforced by a differential in pharmacokinetic parameters significantly favouring the twice-daily regimen(see section5.2).
In addition, the safety and efficacy data and the withholding periods for a specific product may be different depending on local regulation.
Efficacy data to support these claims, including any available standard protocols used,
There are limited safety and efficacy data available in children with Heterozygous Familial Hypercholesterolemia between 6 to 10 years of age derived from open-label studies.
Efficacy data from Study 1007 are summarised in Table 5,
There are limited safety and efficacy data in children below the age of 2 years.
Fluenz's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants
immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.
no conclusive efficacy data for treatments longer than 12 weeks duration are available from placebo- controlled studies.
immunogenicity or efficacy data to support interchangeability of AFLUNOV with other H5N1 monovalent vaccines.
Table 4: 48- and 144-week efficacy data from study GS-01-934 in which emtricitabine, tenofovir disoproxil and efavirenz were administered to antiretroviral-naïve patients with HIV-1 infection.
Efficacy data from ROS1-positive advanced NSCLC patients from Study 1001 are provided in Table 7.
Section 6 headed'Efficacy data' in both Parts A and B of Annex III is replaced by Annex III hereto.
this additional dose is approvable without its own efficacy data and can be based solely on the PK data. .
in the ITT population; therefore, only the efficacy data for the ITT population are presented in Table 8.
Children(< 2 years): there are limited safety and efficacy data in children below the age of 2 years.
Phase 2 study in infants with rapidly progressive LAL Deficiency to explore long-term safety and efficacy data.
In addition to Study 1, efficacy data are available in patients with CD from a single arm Phase 1 study(Study 2).
In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Additional efficacy data are available from 3 single-arm Phase II trials with similar populations treated with the same regime.