Indehaveren af markedsføringstilladelsen (MAH) skal sikre at uddannelsesprogrammet, der er implementeret til den godkendte indikation, behandling af postmenopausal osteoporose, er udvidet til læger, der forventes at udskrive recepter til den nye indikation: behandling af osteoporose hos postmenopausale kvinder og mænd med øget risiko for fraktur, inklusive personer med en nylig lavenergi hoftefraktur.
The Marketing Authorisation Holder (MAH) shall ensure that the educational programme implemented for the authorised indication of treatment of post-menopausal osteoporosis, is extended to the potential prescribers concerned by the new indication: treatment of osteoporosis in post- menopausal women and men at increased risk of fracture, including those with a recent low-trauma hip fracture.