Examples of using Data on the safety in English and their translations into Swedish
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Medicine
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Data on the safety and efficacy in patients under the age of 18 years.
Data on the safety and efficacy of natalizumab beyond 2 years are not available.
Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, double- blind studies.
In July 2004, the CHMP and MAH agreed on a protocol for an observational study 308120 to gather longer-term data on the safety and efficacy of Ventavis iloprost.
There are limited data on the safety and efficacy of OLYSIO in patients older than 65 years.
RILUTEK is not recommended for use in paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Riluzole Zentiva is not recommended for use paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
There are no data on the safety of MabThera in patients with moderate heart failure(NYHA class III) or severe, uncontrolled cardiovascular disease.
collecting and managing data on the safety of medicines, scrutinising at the data to detect‘signals'(any new
There is no clinical data on the safety or efficacy of the 100 mg twice daily dose.
There are inadequate data on the safety and efficacy of ertapenem in patients with severe renal impairment to support a dose recommendation.
There are limited clinical data on the safety and efficacy of further courses of therapy with MabThera.
There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma see section 5.1.
There are only limited data on the safety and efficacy of retigabine in patients aged 65 years and above.
There are only limited data on the safety and efficacy of this dosing interval adjustment guideline.
There is limited clinical data on the safety of CIALIS in patients with severe hepatic insufficiency Child-Pugh Class C.
There are no clinical data on the safety and efficacy of bedaquiline when co-administered with antiretroviral agents.
Since there are no clinical data on the safety of tadalafil in these patients,
There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency Child-Pugh Class C.
There are inadequate data on the safety and efficacy of ertapenem in patients on haemodialysis to support a dose recommendation.
There are limited data on the safety and efficacy of daptomycin in patients aged>
There are currently no data on the safety of taking Tenoten tablets by these categories of patients,
As very few data on the safety of carglumic acid are available,
There are inadequate data on the safety and efficacy of ertapenem in patients with advanced renal impairment
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in HBV infected patients with decompensated liver disease and who have a Child-Pugh-Turcotte(CPT) score> 9.