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ohutusaruanded
safety reports
Last Update: 2014-11-21
Usage Frequency: 4
Quality:
perioodilised ohutusaruanded
100 film-coated tablets
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
11 perioodilised ohutusaruanded
11 • within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • at the request of the emea
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
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perioodilised ohutusaruanded (poa)
periodic safety update reports
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
perioodilised ajakohastatavad ohutusaruanded
psurs
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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2. 3 perioodilised ohutusaruanded
according to the psurs, covering more than 3 years of use, safety is consistent with the details of the spcs.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
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perioodilised ohutusaruanded (poa’ d):
psurs:
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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• vedelikukindluse kontrolli ja ohutusaruanded
• neighbours’ complaints about noise, air, dust and odours
Last Update: 2014-02-06
Usage Frequency: 1
Quality:
10 perioodilised ohutusaruanded (psurid)
10 psurs
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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euroopa ravimiameti palvel perioodilised ohutusaruanded
at the request of the european medicines agency
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
esitada viimase 3 aasta perioodilised ohutusaruanded.
to provide the periodic safety update reports for the last 3 years.
Last Update: 2012-04-11
Usage Frequency: 2
Quality:
perioodilised ajakohastatud ohutusaruanded tuleb esitada elektrooniliselt.
the periodic safety update reports shall be submitted electronically.
Last Update: 2017-04-06
Usage Frequency: 2
Quality:
perioodilised ajakohastatud ohutusaruanded ja muud ohutusega seotud hinnangud
periodic safety update reports and other safety related assessments
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
müügiloa hoidja esitab perioodilised ohutusaruanded aastase tsükliga.
the marketing authorisation holder will continue to submit annual psurs.
Last Update: 2012-04-11
Usage Frequency: 2
Quality:
müügiloa hoidja peab esitama perioodilised ohutusaruanded iga 12 kuu järel.
the marketing authorisation holder should submit 12-monthly psurs.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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müügiloa hoidja esitab jätkuvalt iga 6 kuu järel perioodilised ohutusaruanded.
psurs: the mah will continue to provide periodic safety update reports every 6 months.
Last Update: 2012-04-11
Usage Frequency: 2
Quality:
perioodilised ohutusaruanded (psur) tuleb esitada iga 3 aasta järel.
1.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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perioodilised ohutusaruanded sisaldavad ravimite kasulikkust ja ohtusid käsitlevat teaduslikku hinnangut.
the periodic safety update reports shall include a scientific evaluation of the benefit and risks afforded by the medicinal products.
seejärel esitatakse perioodilised ohutusaruanded iga viie aasta järel koos loa uuendamise taotlusega.
thereafter the periodic safety update reports shall be submitted at five-yearly intervals together with the application for renewal of the authorisation.
perioodilised ajakohastatud ohutusaruanded sisaldavad teaduslikku hinnangut veterinaarravimi kasulikkuse ja ohtude kohta.
the periodic safety update report shall include a scientific evaluation of the benefits and risks afforded by the veterinary medicinal product.