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- oplysninger om overvågningsstudier efter markedsføringen, inklusiv infomation om,
- details of the post marketing surveillance studies including information on how to enroll patients
Last Update: 2012-04-12
Usage Frequency: 2
Quality:
overvågningsstudier pågår og vil give yderligere informationer med hensyn til varigheden af beskyttelsen.
surveillance studies are ongoing and will provide additional information with regard to the duration of protection.
Last Update: 2008-03-04
Usage Frequency: 3
Quality:
Warning: This alignment may be wrong.
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overvågningsstudier og undersøgelser af antistoffernes langtidsvarighed pågår og vil give yderligere oplysninger angående beskyttelsens varighed.
surveillance and antibody long term persistence studies are ongoing and will provide additional information in regards to the duration of protection.
Last Update: 2017-04-26
Usage Frequency: 4
Quality:
at produktet kun må anvendes én gang. oplysninger om overvågningsstudier efter markedsføringen, inklusive infomation om, hvordan patienter skal rekrutteres.
that the product should only be used once details of the post marketing surveillance studies including information on how to enroll patients
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
indehaveren af markedsføringstilladelsen er forpligtet til at levere data fra post- marketing overvågningsstudier for atriance anvendt i gruppen af patienter under 21 år, med den godkendte indikation og en dosering af nelarabin på 650mg/ m2.
the applicant has committed to provide data from a post-marketing surveillance study for atriance in the indicated patient population under 21 years of age receiving the 650mg/ m2 dose of nelarabine.
Last Update: 2012-04-11
Usage Frequency: 3
Quality:
afhængigt af hvordan tysabri-behandlede patienter på nuværende tidspunkt monitoreres nationalt, skal indehaveren af markedsføringstilladelsen og de nationalt ansvarlige myndigheder drøfte og aftale foranstaltninger for yderligere at fremme denne monitorering på passende vis (f.eks. registre, overvågningsstudier efter markedsføringen).
based on how patients treated with tysabri are currently monitored at national level, the marketing authorisation holder (mah) shall discuss and agree with the national competent authorities measures to enhance further this monitoring (e.g. registries, post-marketing surveillance studies) as appropriate.
Last Update: 2017-04-26
Usage Frequency: 1
Quality: