Forskellen vedrører den endometrielle sikkerhed af Activelle 0, 5 mg/ 0, 1 mg, som er blevet utilstrækkeligt påvist i henhold til CHMP' s retningslinjer for HRT- produkter (EMEA/ CHMP/ 021/ 97 rev 1), og dette gav anledning til alvorlig bekymring for folkesundheden.
This refers to endometrial safety of Activelle 0.5 mg/ 0.1 mg, which had been insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/ CHMP/ 021/ 97 rev 1) and this was considered to be of serious public health concern.