검색어: periodic safety update report (독일어 - 영어)

periodic safety update report).
to submit data regarding immunogenicity after re-exposure to idursulfase within the annual psurs.

periodic safety update report) eingereicht werden.
as per the chmp guideline on risk management systems for medicinal products for human use, any updated rmp should be submitted at the same time as the following periodic safety update report (psur).

periodic safety update reports,
periodic safety update reports, follow-up

periodic safety update reports (psur):
periodic safety update reports (psur’ s):

periodic safety update reports (psur).
periodic safety update reports (psur).

periodic safety update reports 2000-2002
8-10 october

periodic safety update reports for marketed drugs
periodic safety update reports for marketed drugs

der zulassungsinhaber wird weiterhin jährlich periodic safety update reports einreichen.
the marketing authorisation holder will continue to submit annual periodic safety update reports.

11 aktualisierte bericht zur unbedenklichkeit (periodic safety update report; psur) zur verfügung gestellt werden.
in addition, an updated rmp should be submitted • when new information is received that may impact on the current safety specification, pharmacovigilance plan or risk minimisation activities

- im rahmen der beurteilung des periodic safety update reports (psur) der
- patients should be instructed never to give this medicinal product to another person and to return

clinical safety data management: periodic safety update reports for marketed drugs
clinical safety data management: periodic safety update reports for marketed drugs

product safety update reports 2000 - 2002 60 49
operating procedure for scientific advice and a new guidance document on scientific advice was published on the emea

der zulassungsinhaber hat weiterhin auf jährlicher basis periodic safety update reports (psurs) einzureichen.
the mah shall continue to submit periodic safety update reports (psurs) on a yearly basis.

19 rmp zur gleichen zeit eingereicht werden wie der nächste periodische bericht zur sicherheit des arzneimittels (periodic safety update report, psur).
when new information is received that may impact on the current safety specification, pharmacovigilance plan or risk minimisation activities.

der inhaber der genehmigung für das inverkehrbringen wird weiterhin periodic safety update reports im 2-jahresrhythmus vorlegen.
the marketing authorisation holder will continue to submit periodic safety update reports on a 2-year cycle.

gemäß den chmp-richtlinien zu risikomanagementsystemen für humanarzneimittel muss der aktualisierte rmp gleichzeitig mit dem nächsten psur (periodic safety update report) eingereicht werden.
as per the chmp guideline on risk management systems for medicinal products for human use, the updated rmp should be submitted at the same time as the next periodic safety update report (psur).

wie in der chmp-guideline zum risikomanagementsystem für humanarzneimittel festgelegt, ist ein aktualisierter rmp zusammen mit dem nächsten periodic safety update report (psur) einzureichen.
as per the chmp guideline on risk management systems for medicinal products for human use, the updated rmp should be submitted at the same time as the next periodic safety update report (psur).

ein aktualisierter rmp ist gemäß der chmp guideline zu risiko-management-systemen für humanarzneimittel mit dem nächsten periodic safety update report (psur) vorzulegen.
as per the chmp guideline on risk management systems for medicinal products for human use, the updated rmp should be submitted at the same time as the next periodic safety update report (psur).

in §63b abs. 5 amg sind die fristen zur vorlage eines periodic safety update reports (psur) folgendermaßen festgelegt:
the deadlines for the submission of psurs are defined in §63b of the german arzneimittelgesetz (amg) as follows:

das allgemeine volumen der aktivitäten im sinne von periodic safety update reports (psurs) erhöhte sich nur leicht gegenüber dem niveau von 2001.
the general volume of activity in terms of periodic safety update reports (psurs) increased only slightly compared to 2001 levels.