Attachment 2. Extract from the Clinical Evaluation Report ...

There is already a LNG intrauterine implant available for this indication (Mirena). However compared with the Mirena duration of five years, LCS12 was developed to provide contraceptive protection for a shorter period of time - up to three years, with both a lower daily release rate of LNG and a smaller size of the system (smaller insertion tube diameter and T-frame) than Mirena. ................
................