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hellefiskreinhardtius hippoglossoidesiia (ef-farvande), vi not subject to restriction not subject to restriction
greenland halibutreinhardtius hippoglossoidesiia (eu waters), vi not subject to restriction not subject to restriction
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
urgent safety restriction- proceduren blev påbegyndt den 16. februar 2005 og afsluttet den 17. februar 2005.
this usr was initiated on 16 february 2005 and finalised on 17 february 2005.
Last Update: 2012-04-11
Usage Frequency: 6
Quality:
der var i chmp enighed om, at det var nødvendigt at iværksætte en urgent safety restriction vedrørende den kardiovaskulære sikkerhed, med indførelse af nye kontraindikationer og skærpede advarsler og oplysninger om bivirkninger i produktresuméet.
the chmp agreed that an urgent safety restriction (usr) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the spc.
Last Update: 2012-04-12
Usage Frequency: 4
Quality:
der var i chmp enighed om, at det var nødvendigt at iværksætte en urgent safety restriction vedrørende kardiovaskulære sikkerhed, med indførelse af nye kontraindikationer og skærpede advarsler og oplysninger om bivirkninger i produktresuméet og indlægssedlen.
the chmp agreed that an urgent safety restriction (usr) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the spc and the package leaflet (pl).
Last Update: 2012-04-12
Usage Frequency: 3
Quality:
chmp bekræftede ændringen af produktinformationen i henhold til den allerede indsendte årlige revurdering, som blev godkendt i april 2005 i forlængelse af urgent safety restriction- proceduren vedrørende sikkerheden i februar, og anmodede om yderligere ændringer.
the chmp confirmed changes to the product information already introduced through the annual re- assessment adopted in april 2005 further to the february usr and requested further changes.
Last Update: 2012-04-12
Usage Frequency: 3
Quality:
Ændringen er som følger: i stedet for ordet exemption skal ordene this restriction indføjes, og efter after legal personality indføjes only apply to the institutions responsible for the administration and management of such iorps, if this restriction cannot be enforced under relevant national law against iorps without legal personality.
the change is as follows: instead of the word 'exemption' the words 'this restriction' should be added, and after 'after legal personality' we add, 'only apply to the institutions responsible for the administration and management of such iorps, if this restriction cannot be enforced under relevant national law against iorps without legal personality.'
Last Update: 2012-02-29
Usage Frequency: 3
Quality: