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- bioequivalence with the monocomponent products has been adequately demonstrated.
- il- bijoekwivalenza mal- prodotti monokomponenti ntweriet b' mod adegwat;
最后更新： 2011-10-23
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an article 29 referral procedure was initiated due to concerns raised by the cz and lv on the potential serious risk to public health regarding insufficient proof of bioequivalence since the applicant did not use the originator´s products (aulin gel) as reference treatments but used monocomponent-containing generics in the originally submitted bioequivalence study.
minħabba tħassib imqajjem minn cz u lv fir - rigward tar- riskji gravi potenzjali għas- saħħa pubblika relatati ma 'prova insuffiċjenti ta' bijoekwivalenza minħabba li l- applikant, fl- istudju ta 'bijoekwivalenza sottomessi oriġinarjament, ma użax il- prodotti tal- oriġinatur (aulin gel) bħala trattament ta' referenza iżda uża mediċini ġeneriċi li fihom monokomponenti, inbdiet proċedura ta 'referenza skont l- artikolu 29.
最后更新： 2011-10-23
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