It is a medicinal product that contains the same active ingredient in the same amount as a reference medicinal product no longer covered by a patent. These medicines also have the same pharmaceutical form, the same route of administration as the reference medicinal product, in addition to a bioequivalence demonstrated by appropriate bioavailability studies. For the purposes of the definition of a generic medicine, it should be borne in mind that the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance if they do not differ significantly in terms of safety and efficacy, and that the various immediate-release oral pharmaceutical forms are considered to be one and the same pharmaceutical form.
From a therapeutic point of view, generic medicines are equivalent to the reference medicinal product and may be used in lieu of it. However, the respective list of excipients reported in the package leaflet needs to be checked in case of subjects with known intolerances.