Примери за използване на Paediatric studies на Английски и техните преводи на Български
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By 26 January 2008, any paediatric studies already completed, by the date of entry into force, in respect of products authorised in the Community shall be submitted
In the paediatric studies APV20003 and APV29005,
In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, a decrease in haemoglobin concentration from baseline to below 10 g/dL was reported in 10.0% of patients.
In three paediatric studies, treatment-naïve(n=123) and treatment-experienced(n=46)
In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, elevations in liver aminotransferases≥ 3× ULN were observed in 2% of patients.
including the database of paediatric studies and the network.
In controlled and open label adult and paediatric studies with adalimumab, serious infections(including fatal infections, which occurred rarely) have been reported,
In controlled and open label adult and paediatric studies with Humira, serious infections(including fatal infections, which occurred rarely) have been reported,
The pregabalin safety profile observed in three paediatric studies in patients with partial seizures with
All existing paediatric studies, as referred to in paragraph 1, and all paediatric studies initiated prior to the entry into force of this Regulation shall be eligible to be included in a paediatric investigation plan,
The pregabalin safety profile observed in four paediatric studies in patients with partial seizures with
The safety profile in this paediatric study was consistent with what has been observed in adults.
Paediatric Study rhLAMAN-08.
No new safety signal was observed in this paediatric study.
In a paediatric study of 48 patients over the age of four years with type 1 diabetes, similar results were observed.
As in the paediatric study described above, fasting plasma glucose reduction from baseline was greater in the insulin glargine group than in the NPH group.
In the pivotal paediatric study, antibody responses to somatropin at two
One paediatric study was also submitted by the MAH, which enrolled 48 patients aged 2 months to 5 years.
In a paediatric study of 48 patients over the age of four years with type 1 diabetes, similar results were observed.
Of the 70 bleeding episodes observed during the paediatric study, 82.9% were controlled with 1 infusion