Examples of using Data on the efficacy in English and their translations into Swedish
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Limitation of data on the efficacy of delamanid.
In respect of particular therapeutic indications, the applicant can show that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because.
There are limited data on the efficacy and safety of Zontivity beyond 24 months.
as there is no data on the efficacy and safety of the drug for a given age.
There are no data on the efficacy of Panretin applied less frequently than twice daily.
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing STOCRIN.
Data on the efficacy and safety of elotuzumab in patients≥ 85 years of age are very limited.
there are no data on the efficacy of entecavir in patients co-infected with hepatitis C
No data on the efficacy and safety of M-M-RVAXPRO for use in children below 9 months of age are currently available.
Co-infection with hepatitis C or D: There are no data on the efficacy of adefovir dipivoxil in patients co-infected with hepatitis C
No data on the efficacy and safety of M-M-RVAXPRO for use in children below 12 months are currently available see section 5.1.
does the Commission have data on the efficacy of the funds which were given
There are no data on the efficacy and safety of the product in concomitant use with bone graft.
There is limited data on the efficacy and safety of Fortacin in patients 65 years and over.
Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
POWER 3: additional data on the efficacy of PREZISTA co-administered with ritonavir 600/100 mg b.i.d. with OBR have been obtained in similar treatment-experienced patients participating in the non-randomised trial TMC114-C215.
This authorisation may be granted only when the applicant can show that he is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use,
There are no data on the efficacy of tenofovir in patients co-infected with hepatitis C
To date there are insufficient data on the efficacy and safety of Trizivir given concomitantly with NNRTIs or PIs.
There are no data on the efficacy of adefovir dipivoxil in patients co-infected with hepatitis C
There are only limited clinical data on the efficacy of bedaquiline in HIV-infected patients not receiving antiretroviral(ARV) therapy.
There are limited data on the efficacy and safety of Brilique beyond 3 years of extended treatment.
To date there are insufficient data on the efficacy and safety of Trizivir given concomitantly with NNRTIs
There are no clinical data on the efficacy of simeprevir in patients with a history of exposure to the NS3/4A PIs telaprevir or boceprevir.
Paediatric hypertension There are limited data on the efficacy and safety of losartan in children
Pediatric hypertension There are limited data on the efficacy and safety of losartan in children
Children below 2 years There are limited data on the efficacy and safety of lamotrigine for adjunctive therapy of partial seizures in children aged 1 month to 2 years see section 4.4.