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psur
psurs

11 psur
11 outside of the pandemic period, the normal psur periodicity and format will be maintained.

psur’ er
psurs

med hver psur
reports - with each

psur-cyklus
psur cycle

standardintervaller for psur.
standard psur timings.

psur/ årlig revurdering
psur/ annual reassessment

27. juni 2009 psur 3:
27 june 2009 psur 3:

periodiske sikkerhedsopdatering (psur)
psur

27. december 2008 psur 2:
27 december 2008 psur 2:

format for den forenklede psur
format of the simplified psur

interime studierapporter – med hver psur
interim study reports - with each psur

safety update report, psur).
(psur).

periodiske, opdaterede sikkerhedsindberetninger (psur)
an updated rmp should be submitted:

indsendelse af psur under en influenzapandemi:
psur submission during the influenza pandemic:

indehaveren af markedsføringstilladelsen vil årligt fremsende psur
the marketing authorisation holder will submit psurs annually.

psur indsendelse af psur under en influenzapandemi:
psur submission during the influenza pandemic:

periodiske, opdaterede sikkerhedsindberetninger (psur`er)
periodic safety update reports

indehaveren af markedsføringstilladelsen skal indsende psur hvert år.
the marketing authorisation holder should submit 12-monthly psurs.

indehaveren af markedsføringstilladelsen vil fortsat indsende årlige psur.
the holder of marketing authorisation will continue to submit annual psurs.