I henhold til myndighedskravene (CHMP/ EWP/ 191583/ 2005) skal der foreligge en formel dokumentation for bioækvivalens, bevis for en bred terapeutisk erfaring og et tilstrækkeligt dokumenteret benefit/ risk- forhold for nye fastdosiskombinationsprodukter, som påberåber sig substitutionsindikation.
In line with the regulatory requirements (CHMP/ EWP/ 191583/ 2005), a formal proof of bioequivalence, evidence of a wide therapeutic experience, and an adequately established benefit/ risk ratio should be demonstrated for new fixed dose combination products claiming substitution indication.