Você procurou por: indikationsafsnittet (Dinamarquês - Inglês)

indehaveren af markedsføringstilladelsen anerkendte, at indikationsafsnittet varierer meget i de forskellige medlemsstater, men at formuleringsforskellene svarer til tre velidentificerede indikationer.
the mah acknowledged that the indication section varies a lot from one member state to the other but that the wording differences corresponded to three well-identified indications.

for primær forebyggelse kan cpmp imidlertid ikke godkende, at “ myokardial revaskularisering ” anføres i indikationsafsnittet, da virkningen af revaskularisering afhænger af klinisk praksis og bør anses for en følge af risikoen forbundet med myokardieinfarktreduktion.
however, as for primary prevention, the cpmp disagreed to mention “ myocardial revascularisation” in the indication section as the effects of revascularisation depends on medical practice and should be considered as a consequence of the myocardial infarction reduction risk.